DSLT for Reducing Medication in Glaucoma

The Eye Institute of West Florida60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

Voyager DSLT

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)

The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment.

Time frame: 6 months post-DSLT treatment

Secondary Outcomes

Change in intraocular pressure (IOP) from baseline

IOP will be measured using Goldmann applanation tonometry at each follow-up visit.

Time frame: 6 months post-DSLT treatment

Proportion of eyes needing medication stratified by number of IOP medications required

Time frame: 6 months post-DSLT treatment

Number and type of Secondary surgical interventions

Time frame: 6 months post-DSLT treatment

DSLT for Reducing Medication in Glaucoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts