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NCT Number: NCT07713056

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

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location status: Recruiting

Location contact

Min Ke, Doctor

CONTACT

[email protected]

+86-18672395959

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Changes in Visual Field Parameters at 6 Months Postoperatively

    Time frame: 6 months postoperatively

    Changes in visual field mean deviation (MD) from baseline to 6 months postoperatively.

  2. Changes in Visual Field Parameters at 6 Months Postoperatively

    Time frame: 6 months postoperatively

    Changes in pattern standard deviation (PSD) from baseline to 6 months postoperatively.

  3. Changes in Visual Acuity at 6 Months Postoperatively

    Time frame: 6 months postoperatively

    Changes in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.

  4. Status of Trabeculotomy Site on Gonioscopy

    Time frame: 6 months postoperatively

    Patency and morphological status of the trabecular meshwork incision site as assessed by gonioscopy at 6 months postoperatively.

  5. Improvement in Pupillary Block and Iris Configuration

    Time frame: 6 months postoperatively

    Improvement in pupillary block and iris configuration as assessed by anterior segment optical coherence tomography (OCT) at 6 months postoperatively.

  6. Rate of Secondary Glaucoma Surgery

    Time frame: From the day of surgery to 6 months postoperatively

    Proportion of patients who require additional glaucoma surgery during the 6-month follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Ke, doctor

CONTACT

[email protected]

18672395959

Xiaomin Chen, doctor

CONTACT

[email protected]

13657237773

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

Clinical Characteristics of Pigmentary Glaucoma and Efficacy Analysis of Ab-interno 120° Trabeculotomy: A Case Series Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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