Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07147647

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Select Eye Care

Elkridge, Maryland, 21075, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

410-821-6400

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients of Black African descent scheduled to undergo DSLT treatment in one or 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 the Hodapp-Anderson-Parrish glaucoma staging system.
  • Treatment naive or washed out IOP at time 0 ranging from ≥ 21 through 32 mm Hg.

Exclusion criteria

  • Screened patients who were on IOP-lowering medications who did not successfully complete 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 the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.
  • Subjects who are pregnant, breast-feeding, or intend to become pregnant during the study period as determined by verbal inquiry.

Treatment and study plan

Direct selective laser trabeculoplasty

Device

DSLT using the Belkin Vision Eagle Device

Primary outcomes

  1. IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP.

    Time frame: 6 Months post-DSLT

Secondary outcomes

  1. Proportion of eyes with ≥ 20% washed out IOP reduction at 6 months post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP.

    Time frame: 6 months post-DSLT

  2. Proportion of medication free eyes at 6 months post-DSLT

    Time frame: 6 Months Post-DSLT

    Eyes not using any glaucoma medications

  3. The number of participants who require secondary interventions (additional IOP-lowering procedures) prior to the completion of the 6 month post-DSLT visit.

    Time frame: 6 Months Post-DSLT

  4. The number of participants who require secondary interventions (additional IOP-lowering medications) prior to the completion of the 6 month post-DSLT visit.

    Time frame: 6 Months Post-DSLT

  5. Change in 1 month and 3 month non-washed out IOP vs washed out baseline IOP

    Time frame: 1 month and 3 months post-DSLT

    Measured in mmHg by Goldmann Applanation Tonometry

  6. Mean 6 month washed out IOP reduction compared with washed out baseline IOP stratified by Trabecular Meshwork pigmentation grade.

    Time frame: 6 Month Post-DSLT

    Trabecular meshwork pigment will be graded on a scale of 0-4 where 0 is no pigment and 4 is heavy pigmentation

Study contacts

Contact information is provided by the study sponsor or research team.

Scott E LaBorwit, MD

CONTACT

[email protected]

410-821-6400

Sponsors and collaborators

Lead sponsor

Select Eye Care

Industry

Registry information

Official study title

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Non-Caucasian Open Angle Glaucoma Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.