NCT06963684

Glaucoma Laser Assessment of Stability and Sustainability

Glaucoma Laser Assessment of Stability and Sustainability: Evaluating Long-Term Stability and Retreatment Efficacy of DSLT in Patients With Ocular Hypertension, Glaucoma Suspects, and Mild/Moderate POAG.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Twin Cities Eye Consultants · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The GLASS Study is designed to help researchers learn whether repeating a non-invasive laser treatment called DSLT (Direct Selective Laser Trabeculoplasty) can better control eye pressure in patients with early-stage glaucoma or ocular hypertension. All participants will receive the laser treatment in both eyes. After three months, one eye will be randomly selected to receive a second treatment, while the other eye will serve as a comparison. The goal is to see whether two treatments work better than one at keeping eye pressure low without using daily eye drops. This study will help doctors decide the best way to use this laser treatment to manage glaucoma and delay the need for medication. Participants will be followed for one year to monitor safety, eye pressure, and the need for any additional treatments.

Detailed description

The GLASS Study (Glaucoma Laser Assessment of Sequential Sessions) is a prospective, interventional, paired-eye, single-site, investigator-initiated clinical trial designed to evaluate the safety and effectiveness of repeated applications of Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naive patients with ocular hypertension (OHT), glaucoma suspect, or mild to moderate primary open-angle glaucoma (POAG). DSLT is a non-contact, automated laser procedure that delivers 120 laser pulses evenly around the limbus to stimulate aqueous outflow by targeting the trabecular meshwork. The procedure is performed with the patient in an upright seated position using the Voyager DSLT device (Alcon). Unlike conventional SLT, this method does not require gonioscopy, coupling gel, or a contact lens. All enrolled subjects must be treatment-naive, meaning they have not previously been on any ocular hypotensive medications. Eligible subjects will first complete a screening visit to verify inclusion and exclusion criteria. If criteria are met, they will be enrolled and proceed to the Baseline visit, where both eyes will undergo DSLT. At the 3-month visit, one randomly selected eye (the "dual-treatment eye") will undergo a second DSLT session. The fellow eye (the "single-treatment eye") will receive no further laser treatment and serve as a control. Subjects will continue follow-up visits at 4 months (1 month after the second treatment), 6 months, 9 months, and 12 months from the baseline treatment. Each study visit will include assessments such as best-corrected visual acuity (BCVA), intraocular pressure (IOP) via Goldmann applanation tonometry, slit-lamp examination, adverse event monitoring, ocular medication review (if applicable), and specular microscopy to assess corneal endothelial cell density. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months. Secondary endpoints include change in IOP from baseline at each follow-up timepoint, time to re-initiation of ocular hypotensive medications, and any difference in safety or complication rates between the two eyes. The hypothesis is that a second treatment at the 3-month mark will provide enhanced and more durable IOP reduction, possibly reducing or delaying the need for medication. While DSLT has been studied previously in single-treatment applications, this is the first prospective trial evaluating repeat bilateral DSLT in a paired-eye design using one eye as its own internal control. All procedures will be conducted at Twin Cities Eye Consultants in Minnesota. The study is sponsored and monitored internally by Twin Cities Eye Consultants' Research Committee, who will oversee compliance, data integrity, and protocol adherence.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)	This is the first clinical study to evaluate repeat bilateral Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naïve patients, using a paired-eye design. Unlike prior SLT studies, which focused on monocular treatment or repeat treatment following IOP rebound, this study randomizes one eye to receive a second DSLT treatment three months after the first, while the fellow eye receives only a single treatment. This allows for a direct intra-subject comparison of efficacy and durability. Existing studies, including GLAUrious and LiGHT, suggest the potential benefits of repeat laser, but no data currently exist for early, scheduled repeat treatment with DSLT. This trial uniquely investigates whether proactively repeating the procedure in a controlled eye extends IOP reduction and delays or reduces the need for topical medications.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-05-09
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study