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

Trial Summary

What is the purpose of this trial?

The purpose of this study to optimize Selective Laser Trabeculoplasty (SLT) application when used in the management of open angle glaucoma (OAG)

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 data supports the effectiveness of the treatment Selective Laser Trabeculoplasty for Open-Angle Glaucoma?

Research shows that Selective Laser Trabeculoplasty (SLT) is effective in lowering eye pressure in patients with open-angle glaucoma, with fewer complications compared to traditional laser treatments. Studies have demonstrated its success in both 180-degree and 360-degree applications, making it a promising option for managing this condition. ^{1 2 3 4 5}

Is Selective Laser Trabeculoplasty (SLT) safe for humans?

Selective Laser Trabeculoplasty (SLT) is generally considered safe for treating open-angle glaucoma, as studies have shown it effectively reduces eye pressure without damaging surrounding tissue. ^{3 5 6 7 8}

How is the treatment Selective Laser Trabeculoplasty (SLT) for open-angle glaucoma different from other treatments?

Selective Laser Trabeculoplasty (SLT) is unique because it uses a laser to target specific pigmented cells in the eye's drainage system without damaging surrounding tissue, which may result in fewer complications compared to traditional laser treatments. It is a non-thermal procedure, meaning it doesn't use heat, which helps prevent damage to the eye's structure. ^{1 4 9 10 11}

Research Team

Arthur Sit

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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 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]

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) 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]

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. Japan pubmed.ncbi.nlm.nih.gov

[Clinical results of selective laser trabeculoplasty]. [2015]

2. United States 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. [2012]

3. United States 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. [2019]

4. France pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2021]

6. Egypt pubmed.ncbi.nlm.nih.gov

Efficacy of selective laser trabeculoplasty in medically uncontrolled glaucoma. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Five-Year Long-Term Follow-Up of Selective Laser Trabeculoplasty in Open-Angle Glaucoma. [2022]

9. Israel pubmed.ncbi.nlm.nih.gov

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

10. Spain pubmed.ncbi.nlm.nih.gov

Bilateral choroidal effusion after selective laser trabeculoplasty. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

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