Laser Treatments for Glaucoma

Overseen By Recruitment Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Brimonidine, Apraclonidine

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: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two laser treatments for open-angle glaucoma, a condition that increases eye pressure and can lead to vision loss. It compares the common method, Selective Laser Trabeculoplasty (SLT), with a newer, simpler method, Direct Selective Laser Trabeculoplasty (DSLT), to determine if DSLT can lower eye pressure as effectively. Participants will receive one of the treatments and will be monitored for changes in eye pressure, medication use, and safety over a year. Individuals with specific types of glaucoma or high eye pressure without previous laser treatment might be suitable candidates. The goal is to determine if the new treatment can improve comfort and access to care for patients. As an unphased trial, this study provides patients the opportunity to contribute to research that could enhance treatment options and accessibility for glaucoma care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that these laser treatments are safe for glaucoma patients?

Research has shown that Selective Laser Trabeculoplasty (SLT) reliably and safely lowers eye pressure in people with glaucoma. Studies indicate that most patients tolerate it well, though some may experience mild inflammation or minor damage to the eye's surface. These side effects are usually not serious and often resolve on their own.

Direct Selective Laser Trabeculoplasty (DSLT) is a newer technique. Early research suggests it might be equally safe. Unlike SLT, DSLT does not require placing a lens on the eye, which can reduce the risk of eye surface damage and inflammation. Although few studies exist, the procedure aims to be as safe as SLT, making DSLT a promising option for those seeking a less invasive treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for glaucoma because they offer innovative approaches to managing intraocular pressure. Direct Selective Laser Trabeculoplasty (DSLT) is unique because it uses a non-contact laser that doesn't require a gonioscopy lens, reducing the risk of corneal damage and inflammation—a significant advantage over standard methods. Meanwhile, Selective Laser Trabeculoplasty (SLT) is already a widely used laser therapy, but it requires more operator expertise and involves placing a lens on the cornea, which can lead to mild discomfort and inflammation. By offering a more patient-friendly option with DSLT and refining SLT techniques, these treatments could improve the safety and comfort of glaucoma management.

What evidence suggests that this trial's laser treatments could be effective for glaucoma?

Research has shown that Selective Laser Trabeculoplasty (SLT), a treatment in this trial, effectively lowers eye pressure, which is crucial for managing open-angle glaucoma. It consistently delivers reliable results over time. Direct Selective Laser Trabeculoplasty (DSLT), another treatment option in this trial, is a newer technique offering similar benefits in reducing eye pressure. Studies suggest DSLT could serve as a good alternative because it avoids contact with the eye, reducing the risk of corneal damage. Both treatments in this trial aim to lower eye pressure to help protect the eye from further harm caused by glaucoma. ^{1 6 7 8 9}

Who Is on the Research Team?

Jella An, MD, MBA

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with open-angle glaucoma, including pigmentary glaucoma. Participants should not have other types of glaucoma and must be suitable candidates for laser eye treatments.

Inclusion Criteria

Gonioscopically visible scleral spur for 360 degrees

Ability to provide informed consent

I have been diagnosed with open-angle glaucoma or high eye pressure.

Exclusion Criteria

Mean intraocular pressure >35 mmHg at screening or baseline visit in either eye

I have narrow or closed angles in my eye.

Pregnancy or plan to become pregnant in the next 1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either DSLT or SLT treatment to reduce intraocular pressure

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits to assess IOP and medication use

What Are the Treatments Tested in This Trial?

Interventions

• DSLT
• SLT

Trial Overview The study compares two laser treatments: the established Selective Laser Trabeculoplasty (SLT) and a new automated Direct SLT (DSLT) using the Eagle system. It aims to see if DSLT can match SLT in lowering eye pressure over a year.

How Is the Trial Designed?

Group I: Arm 2- Selective Laser Trabeculoplasty (SLT) Experimental Treatment 1 Intervention

SLT is a widely used and effective laser therapy to lower intraocular pressure that requires operator expertise and carries risks of mild inflammation, corneal damage and discomfort. This is a standard laser system that requires the use of a gonioscopy lens placed on the cornea to administer.

Group II: Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) Experimental Treatment 1 Intervention

DSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11911663/

First results of direct selective laser trabeculoplasty for the ... Selective laser trabeculoplasty (SLT) is an intraocular pressure (IOP) lowering procedure recognised to be safe and effective in patients with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0161642025002994

Randomized Noninferiority Trial of Direct Selective Laser ... Effective glaucoma treatment is limited by nonadherence to medications and access to selective laser trabeculoplasty (SLT). The GLAUrious study compared ...

3. 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 ...

4. glaucomatoday.com glaucomatoday.com/articles/2022-nov-dec/direct-selective-laser-trabeculoplasty

Direct Selective Laser Trabeculoplasty In 2019, for the first time, high-quality longitudinal data showed a tangible benefit to using selective laser trabeculoplasty (SLT) as primary therapy for ...

5. goodeyes.com goodeyes.com/glaucoma/dslt-glaucoma-treatment-arizona/

DSLT: The Future of Glaucoma Treatment Unlike conventional SLT (Selective Laser Trabeculoplasty), which ... Studies show that DSLT offers comparable IOP-lowering results to traditional ...

6. aaojournal.org aaojournal.org/article/S0161-6420(25)00299-4/fulltext

Randomized Noninferiority Trial of Direct Selective Laser ... Effective glaucoma treatment is limited by nonadherence to medications and access to selective laser trabeculoplasty (SLT). The GLAUrious study compared ...

7. 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- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06925477

Direct vs. Conventional SLT in Open-Angle Glaucoma: A ... This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT ...

9. myalcon.com myalcon.com/professional/glaucoma/voyager-dslt/

Voyager™ DSLT Laser Treatment for Glaucoma | Alcon US Indications: Voyager™ DSLT is indicated for use in selective laser trabeculoplasty (SLT). Contraindications: Use of the Voyager™ DSLT device is contraindicated ...