RECRUITING

Glaucoma Laser Assessment of Stability and Sustainability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2025-06

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06963684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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. * Cataract surgery (if ≥ 2 years or screening) * YAG capsulotomy (if ≥ 60 days of screening)

Inclusion Criteria

Exclusion 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.

* 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.
* Cataract surgery (if ≥ 2 years or screening)
* YAG capsulotomy (if ≥ 60 days of screening)

Contacts and Locations

Study Contact

Hannah Schoenecker

CONTACT

612-999-2020

research@tcecmn.com

Principal Investigator

George R Wandling, MD

PRINCIPAL_INVESTIGATOR

Twin Cities Eye Consultants - Partner

Study Locations (Sites)

Twin Cities Eye Consultants

Coon Rapids, Minnesota, 55433

United States

Collaborators and Investigators

Sponsor: Twin Cities Eye Consultants

George R Wandling, MD, PRINCIPAL_INVESTIGATOR, Twin Cities Eye Consultants - Partner

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-06

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

DSLT
glaucoma
IOP
intraocular pressure

Additional Relevant MeSH Terms

Glaucoma