AphakiaNCT05829122
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
A study testing Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty in people with Aphakia and Mydriasis, run by Changzhou Second People's Hospital affiliated with Nanjing Medical University at 1 site in China.
Trial summary
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of aphakia
- permanently dilated pupils
- history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma
Who cannot join
- iris defects
- severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment
- poorly controlled systemic diseases such as diabetes and hypertension
- corneal endothelial cell counts of <1000/mm2
- <6 months of follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Preoperatively and 6 Months Postoperatively
Changzhou, Jiangsu, 213000
Xincheng Sun, +8613861215676, czeyedoctor@stu.njmu.edu.cn
About this study
Official title: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty for Aphakia and Traumatic Mydriasis
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage pupilloplasty. The modified iris cerclage pupilloplasty was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.
- Being tested
- Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
- Keywords
- Aphakia, Mydriasis
- Medical subject headings
- Aphakia, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage PupilloplastyProcedure or surgery
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, corrected visual acuity, intraocular pressure, pupil diameter, pupil area, corneal endothelial cell count fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage. The modified iris cerclage was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.
| Study group | Role | What they receive |
|---|---|---|
| Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty | Experimental | Not described Receives: Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
logMAR
Measured: preoperatively
best corrected visual acuity
logMAR
Measured: 6 months postoperatively
intraocular pressure
mmHg
Measured: preoperatively
intraocular pressure
mmHg
Measured: 6 months postoperatively
pupil diameter
mm
Measured: preoperatively
pupil diameter
mm
Measured: 6 months postoperatively
corneal endothelial cell count
cell/mm2
Measured: preoperatively
corneal endothelial cell count
cell/mm2
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Jan 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou Second People's Hospital affiliated with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829122
- Sponsor's protocol ID
- XinyuG
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty for Aphakia and Traumatic Mydriasis
- ClinicalTrials.gov ID
- NCT05829122
- Acronym / sponsor ID
- XinyuG
- Keywords
- Aphakia, Mydriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Changzhou Second People's Hospital affiliated with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage pupilloplasty. The modified iris cerclage pupilloplasty was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty | Experimental | Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of aphakia
- permanently dilated pupils
- history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma
Key exclusion criteria (5 listed)
- iris defects
- severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment
- poorly controlled systemic diseases such as diabetes and hypertension
- corneal endothelial cell counts of <1000/mm2
- <6 months of follow-up
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 |
|---|---|---|
| Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage PupilloplastyIn this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, corrected visual acuity, intraocular pressure, pupil diameter, pupil area, corneal endothelial cell count fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage. The modified iris cerclage was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage. | Procedure or surgery | Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty |
Primary outcome
best corrected visual acuity
Time frame: preoperatively
logMAR
best corrected visual acuity
Time frame: 6 months postoperatively
logMAR
intraocular pressure
Time frame: preoperatively
mmHg
intraocular pressure
Time frame: 6 months postoperatively
mmHg
pupil diameter
Time frame: preoperatively
mm
pupil diameter
Time frame: 6 months postoperatively
mm
corneal endothelial cell count
Time frame: preoperatively
cell/mm2
corneal endothelial cell count
Time frame: 6 months postoperatively
cell/mm2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Aphakia
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
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.
Preoperatively and 6 Months Postoperatively
Changzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty in people with Aphakia and Mydriasis, run by Changzhou Second People's Hospital affiliated with Nanjing Medical 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 3 inclusion and 5 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 25 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best corrected visual acuity (time frame: preoperatively). The study lists 8 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 25 Apr 2023.