Glaucoma Laser Assessment of Stability and Sustainability
Part of paid clinical trials in Coon Rapids, Minnesota.
- Sponsor
- Twin Cities Eye Consultants
- Study ID
- NCT06963684
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) — DEVICEThis 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.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2025
- Status verified
- May 2025
- Primary completion
- Jun 30, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental - Dual DSLT TreatmentThis study consists of a single arm using a paired-eye design. All participants will receive DSLT treatment in both eyes at Baseling. Then, one randomized eye receives a second DSLT treatment three months after the first.
Primary Outcome Measure
Mean Decrease in Intraocular Pressure (IOP) from Baseline [ Time Frame: Baseline to Month 3 ]
Central Contacts
- Hannah Schoenecker612-999-2020
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Twin Cities Eye Consultants | Coon Rapids | Minnesota | 55433 | George R Wandling, MD (PRINCIPAL_INVESTIGATOR) Paul C Hammond, OD (SUB_INVESTIGATOR) Calvin Boots, OD (SUB_INVESTIGATOR) |
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