Selective Laser Trabeculoplasty for Open-Angle Glaucoma

Recruiting at 1 trial location

Overseen By Rami Darwich, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Steroids

Disqualifiers: Ocular trauma, Retinal detachment, others

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

Compensation: Varies

Number of Visits: 5

Duration: 3 months

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to use laser treatment to manage open-angle glaucoma, a condition that increases eye pressure and can lead to vision loss. Researchers are testing two laser techniques: Inferior 180° Selective Laser Trabeculoplasty (SLT) and Nasal 180° Selective Laser Trabeculoplasty (SLT), to determine which better lowers eye pressure. Participants should have a history of open-angle glaucoma or high eye pressure and may struggle with current treatments like eye drops. As an unphased trial, this study offers patients the chance to explore innovative laser treatments that could improve their condition.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those currently using steroids. It's best to discuss your specific medications with the trial team.

What prior data suggests that Selective Laser Trabeculoplasty (SLT) is safe for managing open-angle glaucoma?

A previous study found that Selective Laser Trabeculoplasty (SLT) safely and effectively lowers eye pressure in people with open-angle glaucoma. Specifically, SLT reduced eye pressure by an average of 5.7 mmHg, which is crucial for managing glaucoma. Another study found that SLT is well-tolerated, allowing for safe repetition if needed.

Both the Inferior 180° and Nasal 180° SLT treatments have similar safety records. Research shows these treatments significantly lower eye pressure and are safe for patients. The studies reported no serious side effects, indicating that SLT is generally gentle on the eyes.

Overall, SLT is a common and trusted method for managing glaucoma, with studies supporting its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Selective Laser Trabeculoplasty (SLT) for open-angle glaucoma because it offers a non-invasive alternative to traditional treatments like eye drops or surgery. Unlike medications that require daily application, SLT uses a laser to target and improve the eye's natural drainage system, potentially reducing eye pressure with fewer side effects. This technique is distinctive because it can be repeated if necessary and doesn't rely on patient compliance with a daily regimen. With options like Inferior and Nasal SLT, the treatment can be customized to enhance effectiveness and patient comfort.

What evidence suggests that Selective Laser Trabeculoplasty is effective for open-angle glaucoma?

Research has shown that Selective Laser Trabeculoplasty (SLT) effectively lowers eye pressure in people with open-angle glaucoma. In this trial, participants will receive either the Inferior 180° SLT or the Nasal 180° SLT. Studies have found that the Inferior 180° SLT can reduce eye pressure similarly to glaucoma medications over a year, with only a small difference in the change. Another study found that SLT lowered eye pressure by about 4.5 mm Hg after treatment. Research indicates that the Nasal 180° SLT can reduce eye pressure by up to 33% over five years, similar to medical treatments. Overall, both treatments show promising results in managing eye pressure for glaucoma patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Arthur Sit

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Primary Open Angle Glaucoma or Open-Angle Glaucoma. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may be required to meet certain health standards.

Inclusion Criteria

My eye pressure was over 21 mmHg at least twice, with or without treatment.

No adequate IOP control (low treatment compliance, substantial adverse effects with eyedrops, and at least 2 IOP measurements higher than the individualized target IOP)

Mild to moderate visual field defects (24-2 standard mean deviations better than the Swedish interactive thresholding algorithm standard of 12 dB)

Exclusion Criteria

Unwilling or unable to give consent

I have had an eye injury in the past.

I have active inflammation in my eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Nasal 180° Selective Laser Trabeculoplasty (SLT) performed on the right eye

3 months

1 visit (in-person)

Second Treatment

Inferior 180° Selective Laser Trabeculoplasty (SLT) performed on the right eye

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inferior 180° Selective Laser Trabeculoplasty (SLT)
• Nasal 180° Selective Laser Trabeculoplasty (SLT)

Trial Overview The study is testing the effectiveness of two different approaches to Selective Laser Trabeculoplasty (SLT) in managing open angle glaucoma: one targets the nasal half of the eye, while the other targets the inferior half.

How Is the Trial Designed?

Group I: Nasal 180° Selective Laser Trabeculoplasty (SLT) Experimental Treatment 2 Interventions

The Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. After 90 days, the Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye.

Group II: Inferior 180° Selective Laser Trabeculoplasty (SLT) Experimental Treatment 2 Interventions

The Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. After 90 days, the Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Selective laser trabeculoplasty (SLT) significantly reduced intraocular pressure (IOP) in patients with primary open-angle glaucoma, with average reductions of 8.8 mmHg observed post-treatment over a follow-up period of up to 10 months.

The procedure was found to be safe, with no remarkable postoperative complications reported, although some patients experienced transient IOP elevation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical results of selective laser trabeculoplasty]. Kajiya, S., Hayakawa, K., Sawaguchi, S.[2015]

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]

360° selective laser trabeculoplasty (SLT) significantly reduced intraocular pressure (IOP) in patients with medically uncontrolled open-angle glaucoma (OAG), with a success rate of 64.5% over a 12-month follow-up period.

The effectiveness of SLT was consistent regardless of the number of antiglaucomatous medications used, indicating that baseline IOP is a key factor influencing the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of selective laser trabeculoplasty in medically uncontrolled glaucoma. Sayin, N., Alkin, Z., Ozkaya, A., et al.[2022]

Selective laser trabeculoplasty (SLT) effectively reduced intraocular pressure (IOP) in patients with uncontrolled open-angle glaucoma, with an average reduction of 7.1 mm Hg (27.6%) at 24 hours and sustained reductions over 12 months.

While SLT is generally safe, with mild to moderate anterior chamber reactions in some patients, there was a noted tendency for IOP to increase over longer follow-up periods, indicating the need for further studies to assess long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year follow-up of selective laser trabeculoplasty in open-angle glaucoma. Cvenkel, B.[2007]

Selective laser trabeculoplasty (SLT) is an effective treatment for open-angle glaucoma, known for its low risk of complications.

In a case study of a 73-year-old woman, SLT was performed on both eyes, but she developed bilateral choroidal effusion, highlighting a potential complication despite the overall safety profile of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral choroidal effusion after selective laser trabeculoplasty. Hernández Pardines, F., Molina Martín, JC., Fernández Montalvo, L., et al.[2018]

Primary selective laser trabeculoplasty (SLT) is effective in lowering intraocular pressure (IOP) in treatment-naive patients with open-angle glaucoma (OAG) and ocular hypertension (OHT), achieving similar early IOP reductions compared to topical medications.

At 36 months, approximately 75% of patients treated with primary SLT achieved drop-free disease control, indicating long-term efficacy, with a low incidence of complications such as immediate post-laser IOP spikes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Selective Laser Trabeculoplasty for Open-Angle Glaucoma and Ocular Hypertension: Clinical Outcomes, Predictors of Success, and Safety from the Laser in Glaucoma and Ocular Hypertension Trial. Garg, A., Vickerstaff, V., Nathwani, N., et al.[2021]

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]

In a study involving 130 patients with medically uncontrolled open-angle glaucoma, both selective laser trabeculoplasty (SLT) and argon laser trabeculoplasty (ALT) effectively reduced intraocular pressure (IOP) by approximately 3 mmHg over 12 months, but the difference in effectiveness was not statistically significant.

SLT demonstrated a quicker reduction in IOP at early time points (1 week and 1 month) compared to ALT, and showed a trend towards a longer time-to-failure, suggesting SLT may be a more durable treatment option despite the repeat SLT effect being only half as effective as the initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360° Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial. Hutnik, C., Crichton, A., Ford, B., et al.[2019]

Selective laser trabeculoplasty (SLT) is a safe procedure for reducing intraocular pressure (IOP) in open-angle glaucoma patients, with no severe side effects reported in a study of 46 eyes over 5 years.

While SLT showed initial effectiveness in lowering IOP during the first year (27% success rate), its long-term efficacy diminished significantly, with a 100% therapeutic failure rate by the third year, indicating the need for additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Long-Term Follow-Up of Selective Laser Trabeculoplasty in Open-Angle Glaucoma. Gack, C., Laemmer, R., Hohberger, B.[2022]

In a study of 54 patients with open-angle glaucoma, 360-degree selective laser trabeculoplasty (SLT) was found to significantly lower intraocular pressure (IOP) more effectively than 180-degree SLT over an average follow-up of 19.5 months.

The 360-degree SLT not only provided better IOP reduction but also demonstrated higher treatment success rates compared to the 180-degree SLT, indicating it may be a more effective adjunctive treatment option for managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of selective laser trabeculoplasty in open-angle glaucoma in Japanese eyes: comparison of 180 degree with 360 degree SLT. Shibata, M., Sugiyama, T., Ishida, O., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9877405/

Five-year outcomes of selective laser trabeculoplasty Although 51% of eyes had IOP controlled at 5-year post-SLT, mean number of glaucoma medications was significantly higher.

2. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2822693

Responsiveness to Selective Laser Trabeculoplasty in ... Upon completion of the initial SLT, the actual IOP reduction in the eyes undergoing repeat SLT was 4.5 mm Hg (95% CI, 3.9 to 5.1), less than the ...

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

What is the Long-Term Efficacy and Safety of Selective ... SLT achieved IOP reduction comparable to topical medications at 6–12 months post-treatment (mean difference: 0.04 mmHg; 95% CI: –0.27 to 0.34).

4. aoa.org aoa.org/assets/documents/EBO/940-011SCHLOTE2016.pdf

1-year results in early and advanced open angle glaucoma Abstract. The purpose of this study was to examine the efficacy of selective laser trabeculoplasty (SLT) in eyes with early and more advanced stages of open.

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06851546

Efficacy of Selective Laser Trabeculoplasty Targeting ... The purpose of this research is to determine the most effective method in using Selective Laser Trabeculoplasty (SLT) for lowering intraocular pressure (IOP) in ...