Status:
RECRUITING
Glaucoma Laser Assessment of Stability and Sustainability
Lead Sponsor:
Twin Cities Eye Consultants
Collaborating Sponsors:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
40+ years
Phase:
NA
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 ...
Detailed Description
The GLASS Study (Glaucoma Laser Assessment of Sequential Sessions) is a prospective, interventional, paired-eye, single-site, investigator-initiated clinical trial designed to evaluate the safety and ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06963684
Start Date
June 1 2025
End Date
August 1 2027
Last Update
May 14 2025
Active Locations (1)
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1
Twin Cities Eye Consultants
Coon Rapids, Minnesota, United States, 55433