Pigmentary GlaucomaNCT07713056
Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy
An observational study of Pigmentary Glaucoma, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study aims to investigate the clinical characteristics of pigmentary glaucoma and evaluate the efficacy and safety of ab-interno 120° trabeculotomy during the 6-month postoperative follow-up period. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Pigmentary Glaucoma
- What is being tested?
- Ab-interno 120° Trabeculotomy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study included patients with pigmentary glaucoma who underwent primary isolated ab-interno 120° trabeculotomy at Zhongnan Hospital of Wuhan University. All patients had complete baseline data (including intraocular pressure, visual field, and OCT retinal nerve fiber layer measurements) and at least 6 months of follow-up data. Patients with other types of glaucoma, prior ocular trauma or surgery history, combined intraoperative procedures, severe systemic diseases, or incomplete key data were excluded.
Who may be able to join
- Meet the clinical diagnostic criteria for pigmentary glaucoma, with typical signs of pigment dispersion syndrome, extensive trabecular meshwork pigmentation, pathological intraocular pressure elevation, glaucomatous optic nerve damage, and characteristic visual field defects;
- Underwent primary isolated ab-interno 120° trabeculotomy as the initial surgical treatment;
- Have complete preoperative and postoperative examination data, including slit-lamp biomicroscopy, gonioscopy, intraocular pressure, visual field, and OCT RNFL measurements;
- Able to complete regular follow-up for at least 6 months postoperatively.
Who cannot join
- Patients with exfoliation syndrome, exfoliative glaucoma, or other types of primary or secondary glaucoma;
- Patients with a history of ocular trauma, intraocular surgery, uveitis, severe retinopathy, or other ocular diseases affecting intraocular pressure and visual function assessment;
- Patients who underwent combined procedures such as concurrent cataract surgery or other anti-glaucoma surgeries during the operation;
- Patients with severe systemic diseases, cognitive or psychiatric disorders that prevent cooperation with examinations and follow-up;
- Patients with missing key clinical or follow-up data that preclude efficacy and prognosis evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Min Ke, Doctor, +86-18672395959, keminyk@163.com
About this study
Official title: Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study
This study aims to investigate the clinical characteristics of pigmentary glaucoma and evaluate the efficacy and safety of ab-interno 120° trabeculotomy during the 6-month postoperative follow-up period.
Read the detailed description
This is a single-center, retrospective case series study. Patients with pigmentary glaucoma treated at Zhongnan Hospital of Wuhan University will be enrolled. By systematically collecting their baseline demographic characteristics, ocular examination results, and prior treatment history, the study aims to summarize the distribution pattern of clinical features of pigmentary glaucoma. With the 6-month postoperative follow-up as the primary endpoint, the study will evaluate the intraocular pressure-lowering effect of ab-interno 120° trabeculotomy, changes in medication dependence, and the stability of visual field and retinal nerve fiber layer, while observing the occurrence of related intraoperative and postoperative complications, so as to provide clinical evidence for individualized surgical treatment of pigmentary glaucoma.
- Conditions
- Pigmentary Glaucoma
- Being tested
- Ab-interno 120° Trabeculotomy
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ab-interno 120° TrabeculotomyProcedure or surgery
A minimally invasive glaucoma surgery (MIGS) procedure performed via an ab interno approach, involving a 120-degree incision of the trabecular meshwork to improve aqueous humor outflow.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively
Change in intraocular pressure from baseline to 6 months after ab-interno 120° trabeculotomy, including the mean IOP level, absolute reduction, and percentage reduction relative to baseline.
Measured: 6 months postoperatively
Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months
Change in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.
Measured: 6 months postoperatively
Secondary outcomes (6)
Changes in Visual Field Parameters at 6 Months Postoperatively
Changes in visual field mean deviation (MD) from baseline to 6 months postoperatively.
Measured: 6 months postoperatively
Changes in Visual Field Parameters at 6 Months Postoperatively
Changes in pattern standard deviation (PSD) from baseline to 6 months postoperatively.
Measured: 6 months postoperatively
Changes in Visual Acuity at 6 Months Postoperatively
Changes in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.
Measured: 6 months postoperatively
Status of Trabeculotomy Site on Gonioscopy
Patency and morphological status of the trabecular meshwork incision site as assessed by gonioscopy at 6 months postoperatively.
Measured: 6 months postoperatively
Improvement in Pupillary Block and Iris Configuration
Improvement in pupillary block and iris configuration as assessed by anterior segment optical coherence tomography (OCT) at 6 months postoperatively.
Measured: 6 months postoperatively
Rate of Secondary Glaucoma Surgery
Proportion of patients who require additional glaucoma surgery during the 6-month follow-up period.
Measured: From the day of surgery to 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 posted20 Jul 2026
- Study start1 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary GlaucomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Zeng, doctor, Principal investigator, Zhongnan HospitalNan Zhang, doctor, Principal investigator, Zhongnan HospitalXuetian Yu, Principal investigator, The Second Clinical College of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713056
- Sponsor's protocol ID
- 20260523
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study
- ClinicalTrials.gov ID
- NCT07713056
- Acronym / sponsor ID
- 20260523
- Conditions
- Pigmentary Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jul 2026 (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.
This study aims to investigate the clinical characteristics of pigmentary glaucoma and evaluate the efficacy and safety of ab-interno 120° trabeculotomy during the 6-month postoperative follow-up period.
Detailed description
This is a single-center, retrospective case series study. Patients with pigmentary glaucoma treated at Zhongnan Hospital of Wuhan University will be enrolled. By systematically collecting their baseline demographic characteristics, ocular examination results, and prior treatment history, the study aims to summarize the distribution pattern of clinical features of pigmentary glaucoma. With the 6-month postoperative follow-up as the primary endpoint, the study will evaluate the intraocular pressure-lowering effect of ab-interno 120° trabeculotomy, changes in medication dependence, and the stability of visual field and retinal nerve fiber layer, while observing the occurrence of related intraoperative and postoperative complications, so as to provide clinical evidence for individualized surgical treatment of pigmentary glaucoma.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included patients with pigmentary glaucoma who underwent primary isolated ab-interno 120° trabeculotomy at Zhongnan Hospital of Wuhan University. All patients had complete baseline data (including intraocular pressure, visual field, and OCT retinal nerve fiber layer measurements) and at least 6 months of follow-up data. Patients with other types of glaucoma, prior ocular trauma or surgery history, combined intraoperative procedures, severe systemic diseases, or incomplete key data were excluded.
Key inclusion criteria (4 listed)
- Meet the clinical diagnostic criteria for pigmentary glaucoma, with typical signs of pigment dispersion syndrome, extensive trabecular meshwork pigmentation, pathological intraocular pressure elevation, glaucomatous optic nerve damage, and characteristic visual field defects;
- Underwent primary isolated ab-interno 120° trabeculotomy as the initial surgical treatment;
- Have complete preoperative and postoperative examination data, including slit-lamp biomicroscopy, gonioscopy, intraocular pressure, visual field, and OCT RNFL measurements;
- Able to complete regular follow-up for at least 6 months postoperatively.
Key exclusion criteria (5 listed)
- Patients with exfoliation syndrome, exfoliative glaucoma, or other types of primary or secondary glaucoma;
- Patients with a history of ocular trauma, intraocular surgery, uveitis, severe retinopathy, or other ocular diseases affecting intraocular pressure and visual function assessment;
- Patients who underwent combined procedures such as concurrent cataract surgery or other anti-glaucoma surgeries during the operation;
- Patients with severe systemic diseases, cognitive or psychiatric disorders that prevent cooperation with examinations and follow-up;
- Patients with missing key clinical or follow-up data that preclude efficacy and prognosis evaluation.
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 |
|---|---|---|
| Ab-interno 120° TrabeculotomyA minimally invasive glaucoma surgery (MIGS) procedure performed via an ab interno approach, involving a 120-degree incision of the trabecular meshwork to improve aqueous humor outflow. | Procedure or surgery | – |
Primary outcome
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively
Time frame: 6 months postoperatively
Change in intraocular pressure from baseline to 6 months after ab-interno 120° trabeculotomy, including the mean IOP level, absolute reduction, and percentage reduction relative to baseline.
Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months
Time frame: 6 months postoperatively
Change in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.
6 secondary outcomes
Changes in Visual Field Parameters at 6 Months Postoperatively
Time frame: 6 months postoperatively
Changes in Visual Field Parameters at 6 Months Postoperatively
Time frame: 6 months postoperatively
Changes in Visual Acuity at 6 Months Postoperatively
Time frame: 6 months postoperatively
Status of Trabeculotomy Site on Gonioscopy
Time frame: 6 months postoperatively
Improvement in Pupillary Block and Iris Configuration
Time frame: 6 months postoperatively
Rate of Secondary Glaucoma Surgery
Time frame: From the day of surgery to 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pigmentary Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Wen Zeng, doctor principal investigator
Zhongnan Hospital
Nan Zhang, doctor principal investigator
Zhongnan Hospital
Xuetian Yu principal investigator
The Second Clinical College of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmentary Glaucoma, run by Zhongnan 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 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Ke, doctor (18672395959, Keminyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively (time frame: 6 months postoperatively). The study lists 2 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 20 Jul 2026.