Recruiting

Glaucoma Laser

Sponsor:

Twin Cities Eye Consultants

Code:

NCT06963684

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)

Study Details

Brief 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.

Conditions

Glaucoma

Study ID

NCT06963684

Start date

Jun, 2025

Status verified date

May, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients aged 40 years or older
  • A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
  • Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
  • BCVA of 20/50 or better
  • The subject is able to read and understand the requirements of the study and provide written informed consent.
  • The subject is willing to follow study instructions, agrees to comply with all study procedures and attend all scheduled follow-up exams for 12 months after the initial treatment.

Exclusion Criteria:

  • Unable to view scleral spur inferiorly with gonioscopy.
  • Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g. exfoliative, pigmentary, etc.) pigmentary, neovascular glaucoma, closed angle glaucoma, or uveitic glaucoma.
  • Use of oral or ocular hypotensive medication for glaucoma.
  • Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
  • Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration, advanced dry macular degeneration, and proliferative diabetic retinopathy, etc.
  • Clinically significant ocular inflammation or infection within 6 months prior to screening.
  • Previous corneal transplant or clinically significant corneal dystrophy, e.g., Fuch's dystrophy (≥12 confluent guttae)
  • Unclear ocular media prevent visualization of the fundus or anterior chamber angle.
  • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
  • Current participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days.
  • Pregnant or nursing women; or women of childbearing age not using medically acceptable contraceptives.

Accepted prior ocular procedures:

  • Cataract surgery (if ≥ 2 years or screening)
  • YAG capsulotomy (if ≥ 60 days of screening)

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Mean Decrease in Intraocular Pressure (IOP) from Baseline [ Time Frame: Baseline to Month 3 ]

Central Contacts and Locations

Central contacts

Hannah Schoenecker

612-999-2020research@tcecmn.com

Locations

Twin Cities Eye Consultants

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Study Coordinator

612-999-2020research@tcecmn.com

Principal Investigator:

George R Wandling, MD

More Information

Sponsor

Twin Cities Eye Consultants

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • DSLT
  • glaucoma
  • IOP
  • intraocular pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Twin Cities Eye Consultants on 2025-05-14.