This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients.
Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT.
The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment.
The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.
• 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.
• Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0)
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.
Single group
DSLT
DeviceEligible participants will undergo the DSLT procedure: 120 shots, 400 µm spot size, 1.8mJ fixed energy (no titration) delivered at the limbus over 2.4 seconds
Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated with Selective Laser Trabeculoplasty (SLT)
IOP measured using Goldmann applanation tonometry. Washed-out IOP assessed at baseline prior to DSLT and at 6 months post-treatment following protocol-defined medication washout.
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This trial is not recruiting at the moment. You can still explore other options:
