Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy

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.

Study Overview

• Status: Recruiting
• Conditions: Pigmentary Glaucoma
• Intervention / Treatment: Procedure: Ab-interno 120° Trabeculotomy

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 Type: Observational
• Enrollment (Estimated): 11

Contacts and Locations

• Study Contact: Name: Min Ke, doctor; Phone Number: 18672395959; Email: Keminyk@163.com
• Study Contact Backup: Name: Xiaomin Chen, doctor; Phone Number: 13657237773; Email: xminchen@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Min Ke, Doctor; Phone Number: +86-18672395959; Email: keminyk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Visual Field Parameters at 6 Months Postoperatively	Changes in visual field mean deviation (MD) from baseline to 6 months postoperatively.	6 months postoperatively
Changes in Visual Field Parameters at 6 Months Postoperatively	Changes in pattern standard deviation (PSD) from baseline to 6 months postoperatively.	6 months postoperatively
Changes in Visual Acuity at 6 Months Postoperatively	Changes in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.	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.	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.	6 months postoperatively
Rate of Secondary Glaucoma Surgery	Proportion of patients who require additional glaucoma surgery during the 6-month follow-up period.	From the day of surgery to 6 months postoperatively

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Principal Investigator: Wen Zeng, doctor, Zhongnan Hospital; Principal Investigator: Nan Zhang, doctor, Zhongnan Hospital; Principal Investigator: Xuetian Yu, The Second Clinical College of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 20260523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No