By InvitationNot Applicable

Direct vs. Conventional SLT in Open-Angle Glaucoma: A RCT

United States51 participantsStarted 2025-08-07

Plain-language summary

This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. The study will evaluate whether DSLT is as effective as SLT in reducing intraocular pressure (IOP). Participants will be randomly assigned to receive either treatment and will be monitored over 12 months to assess changes in IOP, medication use, and safety outcomes. The goal is to determine if the simpler DSLT procedure can provide similar results to SLT, potentially improving patient comfort and access to glaucoma care.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years. * Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT. * Gonioscopically visible scleral spur for 360 degrees. * Ability to provide informed consent. * In good health, without prior laser trabeculoplasty, with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both. * Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes): * High-risk ocular hypertension (OHT): IOP \> 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of \>0.2 between eyes) \[enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment\] * Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation \>-6.0 dB with no points in the central 5° \<15 dB * Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to \>-12 dB and no more than 1 central 5° point \<15 dB Exclusion Criteria: * Advanced POAG in either eye * Glaucoma other than OAG (including pigmentary and pseudoexfoliation glaucoma) in either eye * Mean IOP \> 35 mmHg at either the screening or baseline visit in either eye * Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye * Contraindications to SLT, brimonidine, apraclonidine, or…

What they're measuring

Primary Endpoint

Timeframe: 6 months

Trial details

NCT IDNCT06925477

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31