Assessing the effects of repeated laser treatment for glaucoma management
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.
This study tests if giving two laser treatments for glaucoma can help keep eye pressure low without needing daily eye drops, compared to just one treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Twin Cities Eye Consultants Academic / other |
| Locations | 1 site (Coon Rapids, Minnesota) |
| Trial ID | NCT06963684 on ClinicalTrials.gov |
What this trial studies
The GLASS Study evaluates the effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in controlling intraocular pressure in patients with early-stage glaucoma or ocular hypertension. Participants will receive the laser treatment in both eyes, with one eye randomly selected for a second treatment after three months, while the other eye serves as a control. The study aims to determine if two treatments are more effective than one in maintaining low eye pressure without the need for daily eye drops. Participants will be monitored for one year to assess safety and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are treatment-naive individuals aged 40 and older with ocular hypertension or mild primary open-angle glaucoma.
Not a fit: Patients with secondary glaucoma, angle closure glaucoma, or those who have previously used ocular hypotensive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for glaucoma patients that reduces reliance on daily medications.
How similar studies have performed: Previous studies have shown promising results with similar laser treatments, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Coon Rapids, Minnesota
- Twin Cities Eye Consultants — Coon Rapids, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: George R Wandling, MD — Twin Cities Eye Consultants - Partner
- Study coordinator: Hannah Schoenecker
- Email: research@tcecmn.com
- Phone: 612-999-2020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.