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.

Inclusion criteria

• • Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye.

• Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG).
• Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 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).
• Recent SLT failures (within 6 months of initial treatment).
• Patients who have undergone cataract surgery within the prior 2 years.
• Secondary glaucoma:

o 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.