Direct Selective Laser Trabeculoplasty to lower eye pressure in non‑Caucasian adults with open-angle glaucoma

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

This trial will try Direct Selective Laser Trabeculoplasty (DSLT) to lower eye pressure in adult non‑Caucasian patients with mild to moderate primary open‑angle glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Select Eye Care (Industry-sponsored)
• Locations: 1 site (Elkridge, Maryland)
• Trial ID: NCT07147647 on ClinicalTrials.gov

What this trial studies

Participants will undergo DSLT in one or both eyes and have vision and intraocular pressure measured at baseline (after medication washout) and at 1, 3, and 6 months after the procedure. The main outcome is the change in washed‑out intraocular pressure at 6 months compared with washed‑out baseline, with success defined as a ≥20% IOP reduction. The study will also report the proportion of eyes free of glaucoma medications at 6 months, the need for additional treatments, and outcomes stratified by trabecular meshwork pigmentation. Eligible participants are adults of Black African descent with mild to moderate primary open‑angle glaucoma and baseline washed‑out IOP between 21 and 32 mmHg.

Who should consider this trial

Good fit: Adults of Black African descent with mild to moderate primary open‑angle glaucoma who are treatment‑naive or can be washed out to an IOP of 21–32 mmHg and who have not had prior glaucoma surgeries are the intended candidates.

Not a fit: Patients with secondary or advanced glaucoma, prior glaucoma surgeries or significant other ocular disease, or those who cannot complete medication washout are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, DSLT could lower eye pressure and reduce or eliminate the need for daily glaucoma medications for some patients.

How similar studies have performed: Selective laser trabeculoplasty (SLT), a related laser treatment, has demonstrated IOP‑lowering benefit in many studies, while DSLT is a newer technique with promising but more limited, population‑specific evidence.

Eligibility criteria

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.

Where this trial is running

Elkridge, Maryland

• Select Eye Care — Elkridge, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Scott E LaBorwit, MD

Conditions Primary Open Angle Glaucoma; Direct Selective Laser Trabeculoplasty; DSLT; POAG; Glaucoma