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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07713056
Enrollment
11
Registered
2026-07-20
Start date
2026-04-01
Completion date
2026-09-30
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pigmentary Glaucoma

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.

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

PROCEDUREAb-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.

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Intraocular Pressure (IOP) at 6 Months Postoperatively6 months postoperativelyChange 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.
Change in the Number of Intraocular Pressure-Lowering Medications at 6 Months6 months postoperativelyChange in the number of glaucoma medications used by patients, comparing baseline to 6 months after surgery.

Secondary

MeasureTime frameDescription
Changes in Visual Field Parameters at 6 Months Postoperatively6 months postoperativelyChanges in visual field mean deviation (MD) from baseline to 6 months postoperatively.
Changes in Visual Acuity at 6 Months Postoperatively6 months postoperativelyChanges in best-corrected visual acuity (BCVA) from baseline to 6 months postoperatively.
Status of Trabeculotomy Site on Gonioscopy6 months postoperativelyPatency and morphological status of the trabecular meshwork incision site as assessed by gonioscopy at 6 months postoperatively.
Improvement in Pupillary Block and Iris Configuration6 months postoperativelyImprovement in pupillary block and iris configuration as assessed by anterior segment optical coherence tomography (OCT) at 6 months postoperatively.
Rate of Secondary Glaucoma SurgeryFrom the day of surgery to 6 months postoperativelyProportion of patients who require additional glaucoma surgery during the 6-month follow-up period.

Countries

China

Contacts

CONTACTMin Ke, doctor
Keminyk@163.com18672395959
CONTACTXiaomin Chen, doctor
xminchen@whu.edu.cn13657237773
PRINCIPAL_INVESTIGATORWen Zeng, doctor

Zhongnan Hospital

PRINCIPAL_INVESTIGATORNan Zhang, doctor

Zhongnan Hospital

PRINCIPAL_INVESTIGATORXuetian Yu

The Second Clinical College of Wuhan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026