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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment for individuals with early-stage glaucoma or high eye pressure to determine if two treatments are more effective than one. Participants will receive a laser treatment in both eyes, and after three months, one eye will undergo an additional treatment. The goal is to manage eye pressure without daily eye drops. This trial suits individuals diagnosed with ocular hypertension or mild glaucoma who have not yet started treatment. Researchers will monitor participants for a year to assess the treatment's effectiveness and safety. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new options for managing eye pressure.

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 prior data suggests that this laser treatment is safe for glaucoma patients?

Previous studies have shown that Direct Selective Laser Trabeculoplasty (DSLT) is quite safe for patients. Research indicates that many patients experience a significant drop in eye pressure after this laser treatment. Specifically, one study found that 56.5% of treated eyes had at least a 20% reduction in eye pressure over six months, suggesting the treatment is effective without serious side effects.

Another study demonstrated that DSLT is safe as a first treatment for glaucoma or high eye pressure, making it a good option for those who haven't tried other treatments. Since DSLT is non-invasive and doesn't involve surgery, it often carries fewer risks.

In summary, DSLT appears well-tolerated, with minimal reports of problems, making it a promising choice for managing eye pressure in glaucoma patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) for glaucoma because it introduces a potentially game-changing approach. Unlike traditional treatments like medicated eye drops or surgical interventions, DSLT uses precise laser technology to improve fluid drainage in the eye, which can lower intraocular pressure. This method is unique because it allows for a non-invasive, targeted treatment that can be applied to both eyes, with the possibility of repeating the procedure for enhanced effectiveness. This could mean fewer side effects and improved outcomes for patients compared to more invasive or medication-heavy options.

What evidence suggests that this laser treatment is effective for glaucoma?

Studies have shown that Selective Laser Trabeculoplasty (SLT), a treatment similar to Direct Selective Laser Trabeculoplasty (DSLT), effectively lowers eye pressure in people with glaucoma. Research indicates that SLT can match the effectiveness of other laser treatments in reducing intraocular pressure. This treatment improves fluid drainage from the eye, thereby lowering pressure. Previous patients have experienced long-term benefits from SLT, suggesting that DSLT might also be effective. Initial findings suggest that DSLT, which participants in this trial will receive, could be a promising non-invasive option for managing early-stage glaucoma and high eye pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

George R Wandling, MD

Principal Investigator

Twin Cities Eye Consultants - Partner

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278128/

Real-world outcomes of selective laser trabeculoplasty and ... Report effectiveness of selective laser trabeculoplasty (SLT) and topical medical therapy for treatment initiation and escalation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07076303

NCT07076303 | A Prospective Study on the Efficacy of ... Direct Selective Laser Trabeculoplasty (DSLT) represents a potential surgical alternative for managing IOP in patients with naive, untreated ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025002753

What is the Long-Term Efficacy and Safety of Selective ... SLT remains an effective long-term treatment option for POAG management. Abstract. Background. Selective laser trabeculoplasty (SLT) is a laser- ...

4. aaojournal.org aaojournal.org/article/S0161-6420(23)00561-4/fulltext

Selective Laser Trabeculoplasty for the Treatment of ... Several level I studies also found that SLT and argon laser trabeculoplasty (ALT) are equivalent in terms of safety and long-term efficacy.

5. nature.com nature.com/articles/s41598-020-66473-0

Predictive Factors for Outcomes of Selective Laser ... Selective laser trabeculoplasty (SLT) reduces intraocular pressure (IOP) by improving aqueous outflow likely by biological rather than anatomic ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/11206721251372801

Clinical efficacy of two modalities of selective laser ... In our real-world cohort, 180° and staggered 360° SLT demonstrated comparable intraocular pressure (IOP)–lowering efficacy over 12 months.

7. bmjophth.bmj.com bmjophth.bmj.com/content/9/1/e001563

Efficacy and safety of first-line or second-line selective ... Selective laser trabeculoplasty (SLT) was effective and safe as a primary treatment for primary open-angle glaucoma and ocular hypertension, and ...