DSLT for Reducing Medication in Glaucoma

Phase

N/A

Condition

Ocular Hypertension

Open Angle Glaucoma

Glaucoma

Treatment

Voyager DSLT

Clinical Study ID

NCT07390890

ND-25-01

All Genders

Study Summary

This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma.

The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT.

Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.

Eligibility Criteria

Inclusion

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

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 systemicdiseases.
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.

Study Design