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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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 effectiveness of repeated applications of Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naive patients with ocular hypertension (OHT), glaucoma suspect, or mild to moderate primary open-angle glaucoma (POAG).
DSLT is a non-contact, automated laser procedure that delivers 120 laser pulses evenly around the limbus to stimulate aqueous outflow by targeting the trabecular meshwork. The procedure is performed with the patient in an upright seated position using the Voyager DSLT device (Alcon). Unlike conventional SLT, this method does not require gonioscopy, coupling gel, or a contact lens.
All enrolled subjects must be treatment-naive, meaning they have not previously been on any ocular hypotensive medications. Eligible subjects will first complete a screening visit to verify inclusion and exclusion criteria. If criteria are met, they will be enrolled and proceed to the Baseline visit, where both eyes will undergo DSLT.
At the 3-month visit, one randomly selected eye (the "dual-treatment eye") will undergo a second DSLT session. The fellow eye (the "single-treatment eye") will receive no further laser treatment and serve as a control. Subjects will continue follow-up visits at 4 months (1 month after the second treatment), 6 months, 9 months, and 12 months from the baseline treatment.
Each study visit will include assessments such as best-corrected visual acuity (BCVA), intraocular pressure (IOP) via Goldmann applanation tonometry, slit-lamp examination, adverse event monitoring, ocular medication review (if applicable), and specular microscopy to assess corneal endothelial cell density. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.
Secondary endpoints include change in IOP from baseline at each follow-up timepoint, time to re-initiation of ocular hypotensive medications, and any difference in safety or complication rates between the two eyes.
The hypothesis is that a second treatment at the 3-month mark will provide enhanced and more durable IOP reduction, possibly reducing or delaying the need for medication. While DSLT has been studied previously in single-treatment applications, this is the first prospective trial evaluating repeat bilateral DSLT in a paired-eye design using one eye as its own internal control.
All procedures will be conducted at Twin Cities Eye Consultants in Minnesota. The study is sponsored and monitored internally by Twin Cities Eye Consultants' Research Committee, who will oversee compliance, data integrity, and protocol adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP at 6 Months Post-DSLT Initiation | Comparison of mean IOP between the once-treated eye and the twice-treated eye at 6 months. | Month 6 |
| Proportion of Eyes Requiring No Additional Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Conjunctival and Corneal Staining for Limbal Stem Cell Deficiency | Evaluation of conjunctival and corneal staining scores (0=no staining, 4=significant staining) to detect potential signs of limbal stem cell deficiency over the course of the study. | Month 3 and Month 12 |
Inclusion Criteria:
Exclusion Criteria:
Accepted prior ocular procedures:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Schoenecker | Contact | 612-999-2020 | research@tcecmn.com |
| Name | Affiliation | Role |
|---|---|---|
| George R Wandling, MD | Twin Cities Eye Consultants - Partner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twin Cities Eye Consultants | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 26834070 | 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. | |
| 26995075 |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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.
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|
Proportion of eyes that remain drop-free and do not require additional glaucoma treatment at 6 and 12 months, comparing once- vs. twice-treated eyes.
| Month 6 and Month 12 |
| Mean IOP at 12 Months Post-DSLT Initiation | Comparison of mean IOP between the once-treated eye and the twice-treated eye at 12 months. | Month 12 |
| Mean Percent Reduction in IOP from Baseline | Mean percentage reduction in IOP from baseline to 6 and 12 months, comparing once- vs. twice-treated eyes. | Month 6 and Month 12 |
| 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. |
| 35173393 | 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. |