Laser Treatment for Glaucoma

(GLASS Trial)

Overseen By Hannah Schoenecker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Twin Cities Eye Consultants

Must not be taking: Hypotensive medications

Disqualifiers: Congenital glaucoma, Secondary glaucoma, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be treatment naïve, meaning you cannot be on any oral or ocular hypotensive medications for glaucoma. If you are currently taking such medications, you would need to stop before participating.

What data supports the effectiveness of the treatment Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) for glaucoma?

Research suggests that DSLT, a new laser technology, may be effective in reducing eye pressure in glaucoma patients, similar to the widely used selective laser trabeculoplasty (SLT). The DSLT procedure is designed to be fast, simple, and safe, potentially offering a broader range of treatment options for glaucoma. ^{1 2 3 4 5}

Is laser treatment for glaucoma safe for humans?

Laser treatments like DSLT and SLT for glaucoma are generally considered safe, with studies showing that side effects are usually minor and temporary. ^{1 2 6 7 8}

How is the Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) treatment different from other glaucoma treatments?

The Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) is unique because it is a rapid, noncontact laser procedure performed directly through the limbus (the border between the cornea and the sclera) without the need for gonioscopy (a procedure to view the eye's drainage angle). This makes it potentially faster and simpler than traditional laser treatments like Selective Laser Trabeculoplasty (SLT), which requires more precise targeting of the eye's drainage system. ^{1 2 4 5 9}

What is the purpose of this trial?

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.

Research Team

George R Wandling, MD

Principal Investigator

Twin Cities Eye Consultants - Partner

Eligibility Criteria

This trial is for individuals with early-stage glaucoma or ocular hypertension. Participants will receive a non-invasive laser treatment in both eyes and must be willing to follow up for one year. Specific eligibility criteria are not provided, but typically participants should have no other major eye diseases and be able to attend all study visits.

Inclusion Criteria

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

Current participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days

I do not have major eye diseases except for cataract or glaucoma.

I cannot see the inner eye angle fully during an eye exam.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Treatment

Both eyes undergo initial DSLT treatment

1 day

1 visit (in-person)

Second Treatment

One eye receives a second DSLT treatment at 3 months

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, eye pressure, and need for additional treatments

12 months

Visits at 4, 6, 9, and 12 months

Treatment Details

Interventions

• Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)

Trial Overview The GLASS Study tests if repeating the DSLT (Direct Selective Laser Trabeculoplasty) on one eye can better manage eye pressure compared to just one treatment. After initial treatment on both eyes, one eye is randomly chosen for a second treatment while the other acts as control.

Participant Groups

Group I: Experimental - Dual DSLT Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Twin Cities Eye Consultants

Lead Sponsor

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Findings from Research

Selective laser trabeculoplasty (SLT) effectively reduced intraocular pressure (IOP) in patients with medically uncontrolled open angle glaucoma, achieving a mean IOP reduction of 21% at 6 months and 20% at 12 months after treatment.

The success rates for SLT were 66% at 6 months and 55% at 12 months, indicating that while it is a viable option for lowering IOP, some patients may still require additional treatments or therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Selective laser trabeculoplasty treatment for medication-refractory open angle glaucoma]. Geyer, O., Wolf, A., Levinger, E., et al.[2007]

Selective laser trabeculoplasty (SLT) effectively reduced intraocular pressure (IOP) by an average of 17.2% over two years in a study of 36 eyes from 26 patients, indicating its potential as a treatment for glaucoma.

While SLT decreased the need for glaucoma medications slightly, it does not completely replace topical treatments, suggesting that patient selection for SLT could be improved to enhance its cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Two-year outcomes of selective laser trabeculoplasty in open-angle glaucoma and ocular hypertension]. Zaninetti, M., Ravinet, E.[2019]

Selective laser trabeculoplasty (SLT) effectively reduces intraocular pressure (IOP) in patients with primary open angle glaucoma and ocular hypertension, achieving a mean IOP reduction of 3.4 mm Hg (15%) at 3 months, 3.0 mm Hg (12.9%) at 12 months, and 2.7 mm Hg (12.1%) at 24 months.

SLT is a safe, non-thermal treatment option that can be used as a first-line therapy or for patients who do not respond to medication, although further long-term studies are needed to understand the sustained effects and biological mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term results after selective laser trabeculoplasty -- a clinical study on 269 eyes]. Best, UP., Domack, H., Schmidt, V.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of unilateral selective laser trabeculoplasty for primary open angle glaucoma]. [2022]

4. Israel pubmed.ncbi.nlm.nih.gov

[Selective laser trabeculoplasty treatment for medication-refractory open angle glaucoma]. [2007]

5. France pubmed.ncbi.nlm.nih.gov

[Two-year outcomes of selective laser trabeculoplasty in open-angle glaucoma and ocular hypertension]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse effects and short-term results after selective laser trabeculoplasty. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Outcome of Selective Laser Trabeculoplasty in Young Patients with Primary Open-Angle Glaucoma and Ocular Hypertension. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Selective Laser Trabeculoplasty: A Clinical Review. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Long-term results after selective laser trabeculoplasty -- a clinical study on 269 eyes]. [2009]