RECRUITINGINTERVENTIONAL

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

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.

Locations (1)

Twin Cities Eye Consultants

Coon Rapids, Minnesota, United States