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) — DEVICE
    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.

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 Treatment
    This 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

Locations (1)

FacilityCityStateZIPSite coordinators
Twin Cities Eye ConsultantsCoon RapidsMinnesota55433
Study Coordinator
612-999-2020
George R Wandling, MD (PRINCIPAL_INVESTIGATOR)
Paul C Hammond, OD (SUB_INVESTIGATOR)
Calvin Boots, OD (SUB_INVESTIGATOR)

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