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Recruiting NCT07713056

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

— Observational Pigmentary Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ab-interno 120° Trabeculotomy.
Who it may be relevant to
Registry conditions: Pigmentary Glaucoma. Basic parameters: 16 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Ab-interno 120° Trabeculotomy
    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 outcome measures

  • Change in Intraocular Pressure (IOP) at 6 Months Postoperatively [Time frame: 6 months postoperatively]
  • Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months [Time frame: 6 months postoperatively]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Zhongnan Hospital of Wuhan University — Wuhan

Identifiers

NCT: NCT07713056 · 20260523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗