GlaucomaNCT05542290
Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
A study testing Capsular tension ring implantation and No capsular tension ring implantation in people with Glaucoma and Angle-Closure, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect… Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Capsular tension ring implantation and No capsular tension ring implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45-79 years old
- Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
- Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)
- The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included
Who cannot join
- Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
- Past history of laser peripheral iridotomy or iridoplasty
- Past history of ocular trauma or signs referring to ocular trauma
- Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
- Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
- Other secondary angle closure glaucoma, including neovascular glaucoma, iritis related secondary glaucoma and so on
- Visualization of capsular equator and infolding of peripheral capsule > 4 clocks during the surgery
- Anterior or posterior capsule rupture during the surgery which makes it impossible for CTR implantation
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital
Beijing, 100730
Chunyan Qiao, M.D., 86017610678637, chunyan_qiao@163.com
About this study
Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.
Read the detailed description
Patients with PACD who are scheduled to have phacoemulsification and IOL implantation combined with goniosynechialysis are recruited. All recruited patients attended comprehensive eye examinations and interviews. Past history of ocular and systemic diseases, family and personal history, history of ocular trauma and surgery were interviewed. And the patients underwent ophthalmic examinations including visual acuity tests (presenting visual acuity [PVA] and best-corrected visual acuity [BCVA]), subjective refraction, intraocular pressure (IOP) measurements, slit-lamp examination, fundus photography, gonioscopy, ocular biometry using IOL Master 700, ultrasound biomicroscopy, anterior segment optical coherence tomography (ASOCT) imaging. All patients provide informed consent for inclusion in the study.
All surgery procedures were performed by the same surgeons (CYQ) using the same standard operation procedure. All patients use the same type of foldable IOL calculated using SRK/T formula. During the surgery, patients with wrinkling of the anterior capsule (multiple sinusoidal folds were formed) during continuous curvilineal capsulorhexis (CCC) at the needle or forceps tip but without infolding of peripheral capsule or visualisation of the capsular equator during the cortical or nuclear removal, or, wrinkling of the anterior capsule during CCC with infolding of peripheral capsule and visualisation of the capsular equator ≤ 4 clocks of range during the cortical or nuclear removal, were finally included in the study and randomly assigned (using a random-number table generated by SAS) with equal probability to either CTR group (with CTR implantation during the surgery) and control group (without CTR implantation during the surgery). All patients included in the CTR group use the same type of CTR. The investigators recorded the complications during the surgery including vitreous prolapse, hyphema, vitreous hemorrhage, damage of iris and lens capsule, et al.
Postoperatively, all patients received similar routine medication comprising topical prednisolone acetate (six times a day for 1 week and tapered down by 1 time every week), topical levofloxacin hydrochloride (four times a day for 1 month), and Tobramycin and Dexamethasone Eye Ointment (1 time every night for 1 month).
Postoperative examinations were performed at 1 day, 1 week, 1 months, 3 months, 6 months and 12 months. During the follow-up visits, a complete ophthalmic examination was performed including PVA, BCVA, subjective refraction, non-contact IOP measurement, slit-lamp examination, slit-lamp photography after pupil dilation, ASOCT, gonioscopy, and fundus imaging.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Capsular tension ring implantation, No capsular tension ring implantation
- Keywords
- angle closure, zonular laxity, zonular dialysis, lens subluxation, capsular tension ring, efficacy, safety
- Medical subject headings
- Glaucoma, Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular tension ring implantationProcedure or surgery
Capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
No capsular tension ring implantationProcedure or surgery
No capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
| Study group | Role | What they receive |
|---|---|---|
| With capsular tension ring implantation | Experimental | We performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis. Receives: Procedure: Capsular tension ring implantation |
| Without capsular tension ring implantation | Other | We performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis. Receives: Procedure: No capsular tension ring implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Measured: baseline
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Measured: 1 month after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Measured: 3 months after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Measured: 6 months after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Measured: 12 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Measured: 1 week after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Measured: 1 month after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Measured: 3 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Measured: 6 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Measured: 12 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Measured: 1 week after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Measured: 1 month after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Measured: 3 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Measured: 6 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Measured: 12 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Measured: baseline
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Measured: 1 month after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Measured: 3 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Measured: 6 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Measured: 12 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Measured: baseline
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Measured: 1 month after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Measured: 3 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Measured: 6 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Measured: 12 months after the surgery
Corneal thickness
Corneal thickness obtained by IOL Master 700
Measured: baseline
Central anterior chamber depth
Central anterior chamber depth obtained by IOL Master 700
Measured: baseline
Lens thickness
Lens thickness obtained by IOL Master 700
Measured: baseline
Axial Length
Axial Length obtained by IOL Master 700
Measured: baseline
Refractive prediction error
Refractive prediction error obtained by IOL Master 700
Measured: baseline
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: baseline
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: baseline
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: baseline
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: baseline
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: baseline
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: baseline
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: baseline
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: baseline
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: baseline
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: baseline
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: 1 week after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: 1 month after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: 3 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: 6 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Measured: 12 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 week after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 month after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Measured: 3 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Measured: 6 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Measured: 12 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 week after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 month after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Measured: 3 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Measured: 6 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Measured: 12 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 week after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Measured: 1 month after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Measured: 3 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Measured: 6 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Measured: 12 months after the surgery
The distance between ciliary body and the equator of lens at 3 o'clock position
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
Measured: baseline
The distance between ciliary body and the equator of lens at 6 o'clock position
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
Measured: baseline
The distance between ciliary body and the equator of lens at 9 o'clock position
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
Measured: baseline
The distance between ciliary body and the equator of lens at 12 o'clock position
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Measured: baseline
Incidence of complications
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
Measured: 1 month after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Measured: 3 months after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Measured: 6 months after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Measured: 12 months after the surgery
Secondary outcomes (28)
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: baseline
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 1 day after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 1 week after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 1 month after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 3 months after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 6 months after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Measured: 12 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Measured: baseline
Best corrected visual acuity
Visual acuity with refractive correction
Measured: 1 month after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Measured: 3 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Measured: 6 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Measured: 12 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: baseline
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 1 day after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 1 week after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 1 month after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 3 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 6 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Measured: 12 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Measured: 1 week after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Measured: 1 month after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Measured: 3 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Measured: 6 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Measured: 12 months after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Measured: baseline
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Measured: 1 month after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Measured: 6 months after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Measured: 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Qiao_2021, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542290
- Sponsor's protocol ID
- BeijingTH-CTR
- Status last verified
- Mar 2023
- First submitted
- 3 Sep 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
- ClinicalTrials.gov ID
- NCT05542290
- Acronym / sponsor ID
- BeijingTH-CTR
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- angle closure, zonular laxity, zonular dialysis, lens subluxation, capsular tension ring, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.
Detailed description
Patients with PACD who are scheduled to have phacoemulsification and IOL implantation combined with goniosynechialysis are recruited. All recruited patients attended comprehensive eye examinations and interviews. Past history of ocular and systemic diseases, family and personal history, history of ocular trauma and surgery were interviewed. And the patients underwent ophthalmic examinations including visual acuity tests (presenting visual acuity [PVA] and best-corrected visual acuity [BCVA]), subjective refraction, intraocular pressure (IOP) measurements, slit-lamp examination, fundus photography, gonioscopy, ocular biometry using IOL Master 700, ultrasound biomicroscopy, anterior segment optical coherence tomography (ASOCT) imaging. All patients provide informed consent for inclusion in the study.
All surgery procedures were performed by the same surgeons (CYQ) using the same standard operation procedure. All patients use the same type of foldable IOL calculated using SRK/T formula. During the surgery, patients with wrinkling of the anterior capsule (multiple sinusoidal folds were formed) during continuous curvilineal capsulorhexis (CCC) at the needle or forceps tip but without infolding of peripheral capsule or visualisation of the capsular equator during the cortical or nuclear removal, or, wrinkling of the anterior capsule during CCC with infolding of peripheral capsule and visualisation of the capsular equator ≤ 4 clocks of range during the cortical or nuclear removal, were finally included in the study and randomly assigned (using a random-number table generated by SAS) with equal probability to either CTR group (with CTR implantation during the surgery) and control group (without CTR implantation during the surgery). All patients included in the CTR group use the same type of CTR. The investigators recorded the complications during the surgery including vitreous prolapse, hyphema, vitreous hemorrhage, damage of iris and lens capsule, et al.
Postoperatively, all patients received similar routine medication comprising topical prednisolone acetate (six times a day for 1 week and tapered down by 1 time every week), topical levofloxacin hydrochloride (four times a day for 1 month), and Tobramycin and Dexamethasone Eye Ointment (1 time every night for 1 month).
Postoperative examinations were performed at 1 day, 1 week, 1 months, 3 months, 6 months and 12 months. During the follow-up visits, a complete ophthalmic examination was performed including PVA, BCVA, subjective refraction, non-contact IOP measurement, slit-lamp examination, slit-lamp photography after pupil dilation, ASOCT, gonioscopy, and fundus imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With capsular tension ring implantation | Experimental | Procedure: Capsular tension ring implantationWe performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis. |
| Without capsular tension ring implantation | Other | Procedure: No capsular tension ring implantationWe performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 45-79 years old
- Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
- Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)
- The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included
Key exclusion criteria (8 listed)
- Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
- Past history of laser peripheral iridotomy or iridoplasty
- Past history of ocular trauma or signs referring to ocular trauma
- Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
- Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsular tension ring implantationCapsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients. | Procedure or surgery | With capsular tension ring implantation |
| No capsular tension ring implantationNo capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients. | Procedure or surgery | Without capsular tension ring implantation |
Primary outcome
Spherical equivalent
Time frame: baseline
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Time frame: 1 month after the surgery
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Time frame: 3 months after the surgery
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Time frame: 6 months after the surgery
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Time frame: 12 months after the surgery
Sphere +1/2 cylinder obtained from subjective refraction
Area of anterior capsulorhexis
Time frame: 1 week after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Time frame: 1 month after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Time frame: 3 months after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Time frame: 6 months after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Time frame: 12 months after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Assessment of posterior capsular opacification
Time frame: 1 week after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Time frame: 1 month after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Time frame: 3 months after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Time frame: 6 months after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Time frame: 12 months after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
The extent of iris-trabecular contact
Time frame: baseline
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
Time frame: 1 month after the surgery
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
Time frame: 3 months after the surgery
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
Time frame: 6 months after the surgery
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
Time frame: 12 months after the surgery
The extent of iris-trabecular contact assessed by gonioscopy
The extent of peripheral anterior synechia
Time frame: baseline
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
Time frame: 1 month after the surgery
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
Time frame: 3 months after the surgery
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
Time frame: 6 months after the surgery
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
Time frame: 12 months after the surgery
The extent of peripheral anterior synechia assessed by gonioscopy
Corneal thickness
Time frame: baseline
Corneal thickness obtained by IOL Master 700
Central anterior chamber depth
Time frame: baseline
Central anterior chamber depth obtained by IOL Master 700
Lens thickness
Time frame: baseline
Lens thickness obtained by IOL Master 700
Axial Length
Time frame: baseline
Axial Length obtained by IOL Master 700
Refractive prediction error
Time frame: baseline
Refractive prediction error obtained by IOL Master 700
Anterior chamber depth
Time frame: baseline
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Time frame: 1 week after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Time frame: 1 month after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Time frame: 3 months after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Time frame: 6 months after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Time frame: 12 months after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: baseline
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: 1 week after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: 1 month after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: 3 months after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: 6 months after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Time frame: 12 months after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: baseline
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: 1 week after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: 1 month after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: 3 months after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: 6 months after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Time frame: 12 months after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: baseline
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: 1 week after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: 1 month after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: 3 months after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: 6 months after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Time frame: 12 months after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: baseline
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: 1 week after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: 1 month after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: 3 months after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: 6 months after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Time frame: 12 months after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: baseline
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: 1 week after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: 1 month after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: 3 months after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: 6 months after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Time frame: 12 months after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: baseline
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: 1 week after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: 1 month after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: 3 months after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: 6 months after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Time frame: 12 months after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: baseline
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: 1 week after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: 1 month after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: 3 months after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: 6 months after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Time frame: 12 months after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: baseline
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: 1 week after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: 1 month after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: 3 months after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: 6 months after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Time frame: 12 months after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Lens vault
Time frame: baseline
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Time frame: 1 week after the surgery
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Time frame: 1 month after the surgery
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Time frame: 3 months after the surgery
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Time frame: 6 months after the surgery
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Time frame: 12 months after the surgery
Lens vault obtained by anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
Time frame: 1 week after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
Time frame: 1 month after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
Time frame: 3 months after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
Time frame: 6 months after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
Time frame: 12 months after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Time frame: 1 week after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Time frame: 1 month after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Time frame: 3 months after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Time frame: 6 months after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Time frame: 12 months after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Time frame: 1 week after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Time frame: 1 month after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Time frame: 3 months after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Time frame: 6 months after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Time frame: 12 months after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
The distance between ciliary body and the equator of lens at 3 o'clock position
Time frame: baseline
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 6 o'clock position
Time frame: baseline
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 9 o'clock position
Time frame: baseline
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 12 o'clock position
Time frame: baseline
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Incidence of complications
Time frame: 1 month after the surgery
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Time frame: 3 months after the surgery
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Time frame: 6 months after the surgery
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Time frame: 12 months after the surgery
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
28 secondary outcomes
Presenting visual acuity
Time frame: baseline
Presenting visual acuity
Time frame: 1 day after the surgery
Presenting visual acuity
Time frame: 1 week after the surgery
Presenting visual acuity
Time frame: 1 month after the surgery
Presenting visual acuity
Time frame: 3 months after the surgery
Presenting visual acuity
Time frame: 6 months after the surgery
Presenting visual acuity
Time frame: 12 months after the surgery
Best corrected visual acuity
Time frame: baseline
Best corrected visual acuity
Time frame: 1 month after the surgery
Best corrected visual acuity
Time frame: 3 months after the surgery
Best corrected visual acuity
Time frame: 6 months after the surgery
Best corrected visual acuity
Time frame: 12 months after the surgery
Intraocular pressure
Time frame: baseline
Intraocular pressure
Time frame: 1 day after the surgery
Intraocular pressure
Time frame: 1 week after the surgery
Intraocular pressure
Time frame: 1 month after the surgery
Intraocular pressure
Time frame: 3 months after the surgery
Intraocular pressure
Time frame: 6 months after the surgery
Intraocular pressure
Time frame: 12 months after the surgery
Number of anti-glaucoma medications
Time frame: 1 week after the surgery
Number of anti-glaucoma medications
Time frame: 1 month after the surgery
Number of anti-glaucoma medications
Time frame: 3 months after the surgery
Number of anti-glaucoma medications
Time frame: 6 months after the surgery
Number of anti-glaucoma medications
Time frame: 12 months after the surgery
Vertical cup-to-disc ratio
Time frame: baseline
Vertical cup-to-disc ratio
Time frame: 1 month after the surgery
Vertical cup-to-disc ratio
Time frame: 6 months after the surgery
Vertical cup-to-disc ratio
Time frame: 12 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsular tension ring implantation and No capsular tension ring implantation in people with Glaucoma and Angle-Closure, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Qiao, M.D. (86-17610678637, chunyan_qiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent (time frame: baseline). The study lists 113 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.