Recruiting

DSLT

Sponsor:

Select Eye Care

Code:

NCT07147647

Conditions

Primary Open Angle Glaucoma (POAG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Direct Selective Laser Trabeculoplasty

Study Details

Brief 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.

Conditions

Primary Open Angle Glaucoma (POAG)

Study ID

NCT07147647

Start date

Jul 16, 2025

Status verified date

Aug, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Direct Selective Laser Trabeculoplasty

Interventions

Direct Selective Laser Trabeculoplasty

DSLT using the Belkin Vision Eagle Device

Primary outcome measure

  • IOP reduction at 6 months washed out post-DSLT compared with washed out baseline IOP. [ Time Frame: 6 Months post-DSLT ]

Central Contacts and Locations

Central contacts

Scott E LaBorwit, MD

410-821-6400scott.laborwit@vipeyes.com

Locations

Select Eye Care

Recruiting

Elkridge, Maryland, United States, 21075

Contacts

Research Coordinator

410-821-6400hshea@vipeyes.com

More Information

Sponsor

Select Eye Care

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

  • Direct Selective Laser Trabeculoplasty
  • DSLT
  • Primary Open Angle Glaucoma
  • POAG
  • Glaucoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Select Eye Care on 2025-08-29.