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

NCT07713056 | Recruiting

• 1 other identifier: 20260523
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pigmentary Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Changes in Visual Field Parameters at 6 Months Postoperatively

  6 months postoperatively

• Changes in Visual Field Parameters at 6 Months Postoperatively

  6 months postoperatively

• Changes in Visual Acuity at 6 Months Postoperatively

  6 months postoperatively

• Status of Trabeculotomy Site on Gonioscopy

  6 months postoperatively

• Improvement in Pupillary Block and Iris Configuration

  6 months postoperatively

Interventions

Ab-interno 120° Trabeculotomy PROCEDURE

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.

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Wen Zeng, doctor

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

• Nan Zhang, doctor

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

• Xuetian Yu

  The Second Clinical College of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ke, doctor

CONTACT

18672395959; Keminyk@163.com

Xiaomin Chen, doctor

CONTACT

13657237773; xminchen@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)