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NCT06963684Recruiting

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.

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
30 Apr 2025
Start date
Jun 2025
Primary completion date
Jun 2027
Lead sponsor
Twin Cities Eye Consultants
NCT number
NCT06963684

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From Jun 2025 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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)
  • 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:

Other illness

  • 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.

Age

  • 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.
  • Cataract surgery (if ≥ 2 years or screening)

Other

  • 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.
  • Unclear ocular media prevent visualization of the fundus or anterior chamber angle.
  • YAG capsulotomy (if ≥ 60 days of screening)

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Twin Cities Eye Consultants
Coordinator of this site? Confirm its status
Coon RapidsUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.