Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT

This is a prospective, single-arm, interventional study designed to evaluate the safety and effectiveness of direct selective laser trabeculoplasty (DSLT) using the Voyager™ DSLT system in patients with ocular hypertension or primary open-angle glaucoma who have previously undergone selective laser trabeculoplasty (SLT). DSLT is a non-contact laser procedure that delivers energy to the trabecular meshwork through the limbus without requiring a gonioscopy lens. The procedure in this study is standardized, consisting of 120 laser applications delivered over 360 degrees using a 400 µm spot size and fixed energy of 1.8 mJ, without titration. Treatment is performed in a single eye per participant. To minimize the confounding effects of topical ocular hypotensive medications, participants using such therapies at screening will undergo a protocol-defined washout period prior to baseline intraocular pressure (IOP) assessment and treatment. Additional washout is required prior to the 6-month follow-up assessment to allow for evaluation of treatment effect independent of adjunctive pharmacologic therapy. IOP is measured using Goldmann applanation tonometry at defined study visits. During follow-up, initiation of IOP-lowering medications is permitted based on investigator-defined target IOP thresholds and clinical judgment. Criteria for treatment escalation and definitions of treatment failure, including the need for secondary glaucoma procedures or ocular surgery that may affect IOP, are specified in the protocol. This study specifically evaluates the performance of DSLT in a population with prior SLT exposure, for whom the magnitude and durability of response to repeat or alternative laser therapy are not well established. The study is intended to generate data on IOP control and safety outcomes in this clinically relevant subgroup under standardized treatment and follow-up conditions.