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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorZhongnan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Ab-interno 120° Trabeculotomy

    Procedure/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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months postoperatively
2

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.

Time frame
6 months postoperatively

Secondary outcomes

1

Changes in Visual Field Parameters at 6 Months Postoperatively

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

Time frame
6 months postoperatively
2

Changes in Visual Field Parameters at 6 Months Postoperatively

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

Time frame
6 months postoperatively
3

Changes in Visual Acuity at 6 Months Postoperatively

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

Time frame
6 months postoperatively
4

Status of Trabeculotomy Site on Gonioscopy

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

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

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