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RecruitingNCT07713056Updated Jul 20, 2026

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

An observational study in Pigmentary Glaucoma, sponsored by Zhongnan Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Zhongnan Hospital · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
11
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pigmentary Glaucoma

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03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 11 is below the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

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Lead sponsor

Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
11 participants (estimated)
Patient registry
No

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.

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What researchers measure

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

  5. Improvement in Pupillary Block and Iris Configuration

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

    Time frame: 6 months postoperatively

  6. Rate of Secondary Glaucoma Surgery

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

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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07713056
Lead sponsor
Zhongnan Hospital
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Apr 1, 2026
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 20, 2026

Study contacts

Min Ke, doctor
Contact
Keminyk@163.com
18672395959
Xiaomin Chen, doctor
Contact
xminchen@whu.edu.cn
13657237773
Wen Zeng, doctor
principal investigator · Zhongnan Hospital
Nan Zhang, doctor
principal investigator · Zhongnan Hospital
Xuetian Yu
principal investigator · The Second Clinical College of Wuhan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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