Selective Laser Trabeculoplasty for Glaucoma

(COAST Trial)

Recruiting at 31 trial locations

Overseen By Monique Barbour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Topical IOP-lowering

Disqualifiers: Advanced POAG, Other glaucoma, others

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

Compensation: Varies

Number of Visits: 12

790 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used eye pressure-lowering medications for more than 6 months in the past 5 years.

What data supports the effectiveness of the treatment Selective Laser Trabeculoplasty for Glaucoma?

The Swedish Optimal SLT Multicenter Randomized Controlled Trial suggests that Selective Laser Trabeculoplasty (SLT) is a first-line treatment for glaucoma and ocular hypertension, indicating its effectiveness in managing these conditions. ^{1 2 3 4 5}

Is Selective Laser Trabeculoplasty (SLT) safe for humans?

Selective Laser Trabeculoplasty (SLT) is generally considered safe for treating glaucoma and ocular hypertension, as indicated by its use as a first-line treatment. However, the Swedish Optimal SLT Multicenter Randomized Controlled Trial notes that there is insufficient comparative evidence on its safety, suggesting that more research is needed to fully understand its safety profile. ^{1 2 4 6 7}

What makes selective laser trabeculoplasty (SLT) unique compared to other glaucoma treatments?

Selective laser trabeculoplasty (SLT) is unique because it uses a laser to target specific pigmented cells in the eye's drainage system, reducing eye pressure without damaging surrounding tissue, unlike older laser treatments that could cause more damage. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.

Research Team

Goundappa K Balasubramani, PhD

Principal Investigator

University of Pittsburgh

Tony Realini, MD, MPH

Principal Investigator

West Virginia University

Stephen Wisniewski, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 with high-risk ocular hypertension or mild to moderate primary open-angle glaucoma, who haven't had any previous treatments. Participants should have good overall health and a vision of at least 20/200. Those with recent eye surgery, advanced glaucoma, certain angle closures in the eye, or inability to attend study visits cannot join.

Inclusion Criteria

Each eye with BCVA 20/200 (UK 6/60) or better

I have been diagnosed with a serious form of eye pressure or glaucoma.

Exclusion Criteria

I don't have eye conditions that would affect pressure measurements.

I have used eye pressure-lowering drops for over 6 months in the past 5 years.

Mean IOP > 35 mmHg at either the screening or baseline visit in either eye

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive initial SLT treatment at either standard or low energy

12 months

Monthly visits for monitoring

Randomization and Repeat Treatment

At month 12, participants are randomized to receive repeat SLT either annually at low energy or as needed at standard energy

36 months

Annual visits for repeat treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Regular visits every 12 months

Treatment Details

Interventions

• Low Energy SLT
• Standard Energy SLT

Trial Overview The study compares two types of SLT therapy for eye conditions: Standard Energy SLT versus Low Energy SLT. It aims to determine if low energy is as effective as standard energy and whether annual low-energy treatments can delay the need for daily medications better than waiting until effects wear off.

Participant Groups

Group I: Trial 2: Month 12 Randomization: Annual Low Energy Repeat SLT Experimental Treatment 1 Intervention

At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ is no bubbles are seen with 5 consecutive spots.

Group II: Trial 1: Initial Low Energy SLT Experimental Treatment 1 Intervention

Note: This arm was discontinued following a planned interim analysis. Low energy SLT will consist of 100 treatment spots delivered at 0.4 mJ per spot throughout the full 360° treatment, with the exception that energy can be reduced to 0.3 mJ if bubbles are seen with 5 consecutive spots and can be increased back to a maximum of 0.4mJ if no bubbles are seen with 5 consecutive spots.

Group III: Trial 1: Initial standard energy SLT Active Control 1 Intervention

Standard energy SLT is performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.

Group IV: Trial 2: Month 12 Randomization: As-Needed Repeat SLT at Standard Energy Active Control 1 Intervention

At month 12, eligible subjects will be randomized to undergo repeat SLT either annually at low energy or as needed at standard energy. Standard SLT will be performed as follows: beginning at 0.8 mJ, energy will be titrated up or down within the first 5-10 spots until champagne bubbles are visualized with every 2nd or 3rd spot. Energy can be titrated throughout the procedure, in response to variations in pigmentation, to ensure the appearance of champagne bubbles with every 2nd or 3rd spot throughout the full 360° treatment. Energy should be increased if no bubbles are seen with 5 consecutive spots and decreased if bubbles are seen with 5 consecutive spots.

Low Energy SLT is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Selective Laser Trabeculoplasty for:

• Glaucoma
• Ocular Hypertension

Approved in European Union as Selective Laser Trabeculoplasty for:

• Glaucoma
• Ocular Hypertension

Approved in Canada as Selective Laser Trabeculoplasty for:

• Glaucoma
• Ocular Hypertension

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Findings from Research

In a study involving 400 patients with glaucoma or ocular hypertension, the 360/high selective laser trabeculoplasty (SLT) protocol significantly reduced intraocular pressure (IOP) by an average of 5.4 mmHg, outperforming other protocols (180/standard, 180/high, and 360/standard) which had lower reductions.

The 360/high SLT protocol also achieved a higher success rate of 58.3% in maintaining IOP reduction after 6 months and extended the time before treatment escalation to over 1323 days, indicating both efficacy and durability of this treatment approach, while maintaining a good safety profile with mostly mild and transient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Performance of Selective Laser Trabeculoplasty: Results from the Swedish Optimal SLT Multicenter Randomized Controlled Trial. Dahlgren, T., Ayala, M., Zetterberg, M.[2023]

Low-level laser therapy (LLLT) significantly improved trabecular bone quality in mice with skeletal unloading, as evidenced by increased bone volume, trabecular thickness, and enhanced populations of osteocytes and osteoblasts after 2 weeks of treatment.

The study demonstrated that LLLT effectively suppresses bone resorption by decreasing osteoclast numbers, indicating its potential as a therapeutic intervention for preventing bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of minimally invasive laser needle system on suppression of trabecular bone loss induced by skeletal unloading. Ko, CY., Kang, H., Ryu, Y., et al.[2021]

Low level light therapy (LLLT) is effective for promoting wound healing, reducing pain and inflammation, and preventing tissue death, making it a valuable tool in various medical fields.

There is preliminary evidence suggesting that pulsed light may have distinct effects compared to continuous wave light, but more research is needed to clarify these differences and optimize treatment parameters for specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pulsing in low-level light therapy. Hashmi, JT., Huang, YY., Sharma, SK., et al.[2021]

Endovenous laser treatment (ELT) using a 1,320-nm Nd:YAG laser requires less energy to induce damage to the saphenous vein wall compared to the 980-nm laser, making it potentially more efficient for treating vein reflux.

Both 980 nm and 1,320 nm lasers show similar closure rates and side effects, indicating that they can be effective alternatives for treating great saphenous vein and small saphenous vein reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mathematical modeling of 980-nm and 1320-nm endovenous laser treatment. Mordon, SR., Wassmer, B., Zemmouri, J.[2016]

Low-level laser therapy (LLLT) has been shown to stimulate the growth, proliferation, and differentiation of osteoporotic mesenchymal stem cells (MSCs), which could improve bone quality and prevent fractures in osteoporosis patients.

Transplanting in vitro laser-treated autologous MSCs into osteoporotic bone sites may enhance bone structure, but further research is needed to fully understand the mechanisms and validate this treatment for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presenting a Method to Improve Bone Quality Through Stimulation of Osteoporotic Mesenchymal Stem Cells by Low-Level Laser Therapy. Bayat, M., Jalalifirouzkouhi, A.[2018]

Low-level laser therapy (LLLT) using pulsed gallium-arsenide laser significantly improved the biomechanical properties of cartilage repair, particularly increasing stiffness at 8 weeks post-treatment in rabbits with osteochondral defects.

In a study involving 41 adolescent male rabbits, LLLT showed no differences in cartilage properties at 4 and 16 weeks, but it did enhance the stiffness of the repaired tissue at 8 weeks compared to the control group, suggesting a potential therapeutic benefit for cartilage healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic effect of low-level laser on repair of osteochondral defects in rabbit knee. Kamali, F., Bayat, M., Torkaman, G., et al.[2019]

Low level laser therapy (LLLT) has been widely used and accepted in Eastern Europe and Asia for various medical conditions, indicating its perceived efficacy among clinicians and patients.

Despite its popularity and reported clinical benefits, LLLT has not yet undergone thorough evaluation through randomized clinical trials in North America and Australasia, highlighting a need for more rigorous research to assess its true value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. Moshkovska, T., Mayberry, J.[2018]

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) 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) has become a widely accepted treatment for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension over the past 20 years.

The review highlights the evolution of SLT from earlier laser treatments and discusses future research directions and emerging technologies that may enhance its effectiveness in glaucoma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty: past, present, and future. Garg, A., Gazzard, G.[2021]

Low-energy selective laser trabeculoplasty (SLT) was found to be effective in reducing intraocular pressure (IOP) in patients with ocular hypertension and glaucoma, showing similar treatment rates to conventional SLT over a 1-year period.

The low-energy SLT resulted in fewer complications, such as postoperative IOP spikes and synechiae, indicating it is a safer option compared to traditional SLT methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of low-energy selective laser trabeculoplasty. Tang, M., Fu, Y., Fu, MS., et al.[2015]

References

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

Optimal Performance of Selective Laser Trabeculoplasty: Results from the Swedish Optimal SLT Multicenter Randomized Controlled Trial. [2023]

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

The effects of minimally invasive laser needle system on suppression of trabecular bone loss induced by skeletal unloading. [2021]

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

Effect of pulsing in low-level light therapy. [2021]

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

Mathematical modeling of 980-nm and 1320-nm endovenous laser treatment. [2016]

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

Presenting a Method to Improve Bone Quality Through Stimulation of Osteoporotic Mesenchymal Stem Cells by Low-Level Laser Therapy. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The therapeutic effect of low-level laser on repair of osteochondral defects in rabbit knee. [2019]

7. England pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. [2018]

8. France pubmed.ncbi.nlm.nih.gov

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

9. Japan pubmed.ncbi.nlm.nih.gov

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

10. Israel pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty: past, present, and future. [2021]

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

The efficacy of low-energy selective laser trabeculoplasty. [2015]