Direct Selective Laser Trabeculoplasty to reduce glaucoma medications

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma

This study will try Direct Selective Laser Trabeculoplasty (DSLT) to reduce the number of eye-drop medications in adults with medically controlled primary open-angle glaucoma or ocular hypertension.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: The Eye Institute of West Florida (Academic / other)
• Locations: 1 site (Largo, Florida)
• Trial ID: NCT07390890 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label study at a single site using DSLT delivered with 120 shots, 400 µm spot size, and 1.8 mJ fixed energy applied at the limbus over 2.4 seconds. The primary endpoint is change in medication count at 6 months versus baseline, with secondary endpoints including absolute and percent IOP reduction, complete success rate without medication increase, proportion of eyes needing medication at 6 months, and need for secondary surgical interventions. Participants will be followed at 1, 3, and 6 months with IOP measured by calibrated Goldmann applanation tonometry. Adults on 1–3 topical ocular hypotensive agents with IOP ≤21 mmHg and a diagnosis of POAG or ocular hypertension are enrolled, excluding those with prior glaucoma surgery, recent cataract surgery, secondary glaucomas, or other significant ocular comorbidities.

Who should consider this trial

Good fit: Adults with medically controlled primary open-angle glaucoma or ocular hypertension on 1–3 topical agents with IOP ≤21 mmHg, no prior glaucoma surgeries, and no recent cataract or secondary glaucoma are ideal candidates.

Not a fit: Patients with prior glaucoma surgeries, secondary forms of glaucoma, cataract surgery within the past two years, or other significant ocular disease are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, DSLT could lower or eliminate the need for daily glaucoma eye drops, improving adherence and reducing medication side effects.

How similar studies have performed: Conventional selective laser trabeculoplasty (SLT) has established evidence for lowering IOP and reducing medication burden, and early automated DSLT reports show similar promise though DSLT-specific data are more limited.

Eligibility criteria

Inclusion Criteria:

* Adult patients scheduled to undergo DSLT treatment in one or both eyes.

  * Diagnosis of ocular hypertension or primary open angle glaucoma (POAG).
* Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.

Exclusion Criteria:

* Previous glaucoma surgeries/interventions:

  * Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
* Patients who have undergone cataract surgery within the prior 2 years.
* 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.

Where this trial is running

Largo, Florida

• The Eye Institute of West Florida — Largo, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Neel Desai, MD — The Eye Institute of West Florida
• Study coordinator: Renee Bondurant

Conditions Primary Open Angle Glaucoma; Ocular Hypertension