Glaucoma Laser Assessment of Stability and Sustainability

NCT06963684 | Recruiting FDA Device

• 1 other identifier: TCEC-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glaucoma

Keywords

DSLT; glaucoma; IOP; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Mean Decrease in Intraocular Pressure (IOP) from Baseline

  Mean IOP reduction from untreated baseline (T0) to 3 months following bilateral DSLT, averaged between both eyes at the two timepoints.

  Baseline to Month 3

Secondary Outcomes (4)

• Mean IOP at 6 Months Post-DSLT Initiation

  Month 6

• Proportion of Eyes Requiring No Additional Treatment

  Month 6 and Month 12

• Mean IOP at 12 Months Post-DSLT Initiation

  Month 12

• Mean Percent Reduction in IOP from Baseline

  Month 6 and Month 12

Other Outcomes (1)

• Change in Conjunctival and Corneal Staining for Limbal Stem Cell Deficiency

  Month 3 and Month 12

Study Arms (1)

Experimental - Dual DSLT Treatment

EXPERIMENTAL

This study consists of a single arm using a paired-eye design. All participants will receive DSLT treatment in both eyes at Baseling. Then, one randomized eye receives a second DSLT treatment three months after the first.

Device: Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)

Interventions

Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) DEVICE

This is the first clinical study to evaluate repeat bilateral Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naïve patients, using a paired-eye design. Unlike prior SLT studies, which focused on monocular treatment or repeat treatment following IOP rebound, this study randomizes one eye to receive a second DSLT treatment three months after the first, while the fellow eye receives only a single treatment. This allows for a direct intra-subject comparison of efficacy and durability. Existing studies, including GLAUrious and LiGHT, suggest the potential benefits of repeat laser, but no data currently exist for early, scheduled repeat treatment with DSLT. This trial uniquely investigates whether proactively repeating the procedure in a controlled eye extends IOP reduction and delays or reduces the need for topical medications.

Experimental - Dual DSLT Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Twin Cities Eye Consultants: lead
• Alcon Research: collaborator

Study Sites (1)

Twin Cities Eye Consultants

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Related Publications (4)

• Guo, Y., Ioannidou, A., & Jute, P. (2019). Selective laser trabeculoplasty: a review of repeatability. Annals Of Eye Science, 4(4), 20. doi:10.21037/aes.2019.05.01

  BACKGROUND

• Polat J, Grantham L, Mitchell K, Realini T. Repeatability of selective laser trabeculoplasty. Br J Ophthalmol. 2016 Oct;100(10):1437-41. doi: 10.1136/bjophthalmol-2015-307486. Epub 2016 Feb 1.

  PMID: 26834070 BACKGROUND

• Durr GM, Harasymowycz P. The effect of repeat 360-degree selective laser trabeculoplasty on intraocular pressure control in open-angle glaucoma. J Fr Ophtalmol. 2016 Mar;39(3):261-4. doi: 10.1016/j.jfo.2015.10.008. Epub 2016 Mar 16.

  PMID: 26995075 BACKGROUND

• Jang HJ, Yu B, Hodge W, Malvankar-Mehta MS. Repeat Selective Laser Trabeculoplasty for Glaucoma Patients: A Systematic Review and Meta-analysis. J Curr Glaucoma Pract. 2021 Sep-Dec;15(3):117-124. doi: 10.5005/jp-journals-10078-1302.

  PMID: 35173393 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• George R Wandling, MD

  Twin Cities Eye Consultants - Partner

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Schoenecker

CONTACT

612-999-2020; research@tcecmn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive DSLT treatment in both eyes at Baseline. 3-months later, one eye will be randomized to receive a second DSLT treatment. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)