Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma

Last updated: August 22, 2025
Sponsor: Select Eye Care
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Direct Selective Laser Trabeculoplasty

Clinical Study ID

NCT07147647
25-SG27
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to to evaluate how well Direct Selective Laser Trabeculoplasty (DSLT) lowers eye pressure in eyes of adult, non-Caucasian participants with primary open angle glaucoma. The main question it aims to answer is:

What is the washed out eye pressure (eye pressure when not on any glaucoma medications) of participants 6 months after the Direct Selective Laser Trabeculoplasty (DSLT) procedure compared to the washed out eye pressure of participants prior to the DSLT procedure.

Participants will:

Undergo the DSLT procedure in one or both eyes and visit the clinic 1 month, 3 months, and 6 months after the procedure to have their vision and eye pressure measured.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients of Black African descent scheduled to undergo DSLT treatment in oneor both eyes.

  • Diagnosis of mild to moderate primary open angle glaucoma (POAG).

  • Mild to moderate POAG will be defined as Stage 2 or better of theHodapp-Anderson-Parrish glaucoma staging system.

  • Treatment naive or washed out IOP at time 0 ranging from ≥ 21 through 32 mm Hg.

Exclusion

Exclusion Criteria:

  • Screened patients who were on IOP-lowering medications who did not successfullycomplete medication washout at the time of the procedure (time 0).

  • Previous glaucoma surgeries/interventions:

  • Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy,laser trabeculoplasty, MIGS, or tube shunt).

  • Secondary glaucoma:

  • Patients with secondary forms of glaucoma, such as angle-closure glaucoma,neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.

  • Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate theassessment of intraocular pressure (IOP) or visual function as deemed by theinvestigator.

  • Subjects who are pregnant, breast-feeding, or intend to become pregnant during thestudy period as determined by verbal inquiry.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Direct Selective Laser Trabeculoplasty
Phase:
Study Start date:
July 16, 2025
Estimated Completion Date:
October 31, 2026

Study Description

The goal of this clinical trial is to evaluate intraocular pressure (IOP) reduction of Direct Selective Laser Trabeculoplasty (DSLT) treatment in eyes of non-Caucasian patients with primary open angle glaucoma by assessing the washed out IOP reduction of DSLT at 6 months (compared to washed out baseline IOP), measuring the success rate of achieving ≥ to 20% IOP reduction from washed out baseline, assessing the proportion of medication-free eyes at 6 months post-DSLT, the need for secondary intervention (additional medications or procedures) at 6 months post-DSLT, and by comparing the washed out IOP reduction at 6 months post-DSLT compared to the washed out baseline IOP according to trabecular meshwork pigmentation grade.

Connect with a study center

  • Select Eye Care

    Elkridge 4354256, Maryland 4361885 21075
    United States

    Active - Recruiting

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