IOP Reduction in Pigmentary Glaucoma Using DSLT

April 8, 2026 updated by: Mann Eye Institute

Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients

This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 76134-2099
        • Recruiting
        • Mann Eye Institute
        • Contact:
        • Principal Investigator:
          • Alex Hacopian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible test subjects will be adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.

Description

Inclusion Criteria:

  • Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
  • Treatment naive, or washed out IOP ranging from ≥18-34 mmHg
  • Central corneal thickness (CCT) 480-600 µm
  • Able to complete medication washout and follow-up

Exclusion Criteria:

  • Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
  • Prior laser trabeculoplasty <3 years
  • Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years
  • Patients anticipating cataract surgery within the follow-up period
  • History of ocular inflammation and infection
  • All other secondary glaucoma including exfoliative
  • Patients unable to have DSLT treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP
Time Frame: 6 months post-DSLT
6 months post-DSLT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Time Frame: 6 months post-DSLT
6 months post-DSLT
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Time Frame: 12 months post-DSLT
12 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Time Frame: 6 months post-DSLT
6 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Time Frame: 12 months post-DSLT
12 months post-DSLT
Change in number of glaucoma medication(s)
Time Frame: 6 months post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
6 months post-DSLT
Change in number of glaucoma medication(s)
Time Frame: 12 months post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
12 months post-DSLT
Proportion of medication free eyes post-DSLT
Time Frame: 6 months post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
6 months post-DSLT
Proportion of medication free eyes post-DSLT
Time Frame: 12 months post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
12 months post-DSLT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mann Eye Institute

Collaborators

Sengi

Investigators

  • Principal Investigator: Alex Hacopian, MD, Mann Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AH-25-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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