Assessing the effects of repeated laser treatment for glaucoma management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Removing the ripcord from a glaucoma drainage device after 3 months

  This study tests whether removing the ripcord from an implanted glaucoma drainage device changes eye pressure for adults with open-angle glaucoma.

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• Glaucoma and Brain Changes: How Brain Structure and Size See What Glaucoma Is Doing

  This study tests whether glaucoma is linked to broader brain changes by comparing brain MRI and eye health over time in people with glaucoma and matched controls.

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• Long-Term Results After Ab-interno Trabeculotomy for Glaucoma

  This study tests whether ab-interno trabeculotomy with the Trabectome can provide sustained intraocular pressure reduction in glaucoma patients who had the procedure between 2019 and 2021.

  Recruiting Wuerzburg University Hospital · Würzburg, Bavaria · NCT07780916

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.