Glaucoma, Angle-ClosureNCT04703712
Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy
A study testing Lens extraction combined with goniosynechialysis and Trabeculectomy surgery in people with Glaucoma, Angle-Closure, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Lens extraction combined with goniosynechialysis and Trabeculectomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2021to Dec 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 years old to 80 years old
- more than 180-degree synechial closure of anterior chamber angle on gonioscopy
- IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
- mean deviation of visual field worse than -12dB on Humphrey 24-2
- phakic eyes
Who cannot join
- Snellen visual acuity worse than 0.02
- history of ocular trauma
- uveitis
- previous ocular surgeries
- significant conjunctival scar
- visible neovascular on iris or anterior chamber angle
- other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital
Shanghai, 200031
Feng Gao, Doctor, 021-64377134, fenggao@fudan.edu.cn
About this study
Official title: Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial
To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.
Read the detailed description
Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Lens extraction combined with goniosynechialysis, Trabeculectomy surgery
- Keywords
- phacoemulsification, goniosynechialysis, trabeculectomy
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens extraction combined with goniosynechialysisProcedure or surgery
The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
Trabeculectomy surgeryProcedure or surgery
The patients enrolled underwent trabeculectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Lens extraction combined with goniosynechialysis group | Active comparator | One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis. Receives: Procedure: Lens extraction combined with goniosynechialysis |
| Trabeculectomy Group | Active comparator | One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy. Receives: Procedure: Trabeculectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) change at one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
Measured: one month
IOP change at three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
Measured: three months
IOP change at six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
Measured: six months
IOP change at one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
Measured: one year
IOP change at two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
Measured: two years
IOP change at three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Measured: three years
Best corrected visual acuity at one month
Best corrected visual acuity of participants after surgery at one month
Measured: one month
Best corrected visual acuity at three months
Best corrected visual acuity of participants after surgery at three months
Measured: three months
Best corrected visual acuity at six months
Best corrected visual acuity of participants after surgery at six months
Measured: six months
Best corrected visual acuity at one year
Best corrected visual acuity of participants after surgery at one year
Measured: one year
Best corrected visual acuity at two years
Best corrected visual acuity of participants after surgery at two years
Measured: two years
Best corrected visual acuity at three years
Best corrected visual acuity of participants after surgery at three years
Measured: three years
Secondary outcomes (5)
Mean deviation
The mean deviation value of Humphery visual filed tests before and after surgery.
Measured: one month, three months, six months, one year, two years, three years
The thickness of retinal nerve fiber layer (RNFL)
The RNFL thickness measured by optical coherence topography (OCT)
Measured: one month, three months, six months, one year, two years, three years
The thickness of ganglion cell complex (GCC)
The GCC thickness measured by OCT
Measured: one month, three months, six months, one year, two years, three years
Number of eye drops
The number of eye drops after surgery.
Measured: one month, three months, six months, one year, two years, three years
Adverse event
Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage
Measured: one month, three months, six months, one year, two years, three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start30 Jan 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhong Chen, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703712
- Sponsor's protocol ID
- AAC Glaucoma
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04703712
- Acronym / sponsor ID
- AAC Glaucoma
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- phacoemulsification, goniosynechialysis, trabeculectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jan 2021 (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.
To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.
Detailed description
Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens extraction combined with goniosynechialysis group | Active comparator | Procedure: Lens extraction combined with goniosynechialysisOne hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis. |
| Trabeculectomy Group | Active comparator | Procedure: Trabeculectomy surgeryOne hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 years old to 80 years old
- more than 180-degree synechial closure of anterior chamber angle on gonioscopy
- IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
- mean deviation of visual field worse than -12dB on Humphrey 24-2
- phakic eyes
Key exclusion criteria (7 listed)
- Snellen visual acuity worse than 0.02
- history of ocular trauma
- uveitis
- previous ocular surgeries
- significant conjunctival scar
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 |
|---|---|---|
| Lens extraction combined with goniosynechialysisThe patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery. | Procedure or surgery | Lens extraction combined with goniosynechialysis group |
| Trabeculectomy surgeryThe patients enrolled underwent trabeculectomy surgery | Procedure or surgery | Trabeculectomy Group |
Primary outcome
Intraocular pressure (IOP) change at one month
Time frame: one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
IOP change at three months
Time frame: three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
IOP change at six months
Time frame: six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
IOP change at one year
Time frame: one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
IOP change at two years
Time frame: two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
IOP change at three years
Time frame: three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Best corrected visual acuity at one month
Time frame: one month
Best corrected visual acuity of participants after surgery at one month
Best corrected visual acuity at three months
Time frame: three months
Best corrected visual acuity of participants after surgery at three months
Best corrected visual acuity at six months
Time frame: six months
Best corrected visual acuity of participants after surgery at six months
Best corrected visual acuity at one year
Time frame: one year
Best corrected visual acuity of participants after surgery at one year
Best corrected visual acuity at two years
Time frame: two years
Best corrected visual acuity of participants after surgery at two years
Best corrected visual acuity at three years
Time frame: three years
Best corrected visual acuity of participants after surgery at three years
5 secondary outcomes
Mean deviation
Time frame: one month, three months, six months, one year, two years, three years
The thickness of retinal nerve fiber layer (RNFL)
Time frame: one month, three months, six months, one year, two years, three years
The thickness of ganglion cell complex (GCC)
Time frame: one month, three months, six months, one year, two years, three years
Number of eye drops
Time frame: one month, three months, six months, one year, two years, three years
Adverse event
Time frame: one month, three months, six months, one year, two years, three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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 Lens extraction combined with goniosynechialysis and Trabeculectomy surgery in people with Glaucoma, Angle-Closure, run by Eye & ENT Hospital of Fudan University 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 5 inclusion and 7 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 1 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 Feng Gao, Doctor ((86)021-64377134, fenggao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) change at one month (time frame: one month). The study lists 12 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 1 Mar 2023.