Direct SLT for Pseudoexfoliation Syndrome

Not yet recruiting at 2 trial locations
LP
DD
Overseen ByDana Dubas
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Vance Thompson Vision
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Direct Selective Laser Trabeculoplasty, which aims to help people with pseudoexfoliation glaucoma, a type of eye disease that causes high pressure and optic nerve damage. The main goal is to determine if this laser treatment can effectively lower eye pressure and improve outcomes for those affected. Suitable participants are adults diagnosed with pseudoexfoliation glaucoma who have not received similar treatments and have a specific level of vision and field loss in the eye being studied. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to new insights and advancements in treating pseudoexfoliation glaucoma.

Will I have to stop taking my current medications?

The trial requires participants to stop taking their current medications for a period of time before starting the study, known as a 'washout period' (time without taking certain medications).

What prior data suggests that Direct Selective Laser Trabeculoplasty is safe for patients with pseudoexfoliative glaucoma?

A previous study found selective laser trabeculoplasty (SLT) to be generally safe. Reports indicated a few side effects, such as mild eye irritation, but these were uncommon. Another study examined SLT's long-term use and found it to be quite safe, with low rates of serious issues. Experts describe Direct Selective Laser Trabeculoplasty (DSLT) as a newer form of this treatment. While researchers continue to study DSLT, it is expected to have a safety profile similar to SLT, suggesting that most people tolerate it well.12345

Why are researchers excited about this trial?

Direct Selective Laser Trabeculoplasty (DSLT) is unique because it uses a laser to target and improve the drainage of fluid in the eye, specifically for those with Pseudoexfoliation Syndrome. Unlike traditional treatments that often rely on eye drops or more invasive surgeries, DSLT offers a non-invasive approach that can be performed quickly and with minimal discomfort. Researchers are excited about DSLT because it holds the promise of reducing eye pressure effectively with fewer side effects and less frequent follow-up treatments compared to current options.

What evidence suggests that Direct Selective Laser Trabeculoplasty is effective for pseudoexfoliative glaucoma?

Research shows that Direct Selective Laser Trabeculoplasty (DSLT), which participants in this trial will receive, effectively treats glaucoma. Studies have found that DSLT safely lowers intraocular pressure, crucial for managing glaucoma. The LiGHT trial discovered that this method serves as a good first choice for treating open-angle glaucoma and high eye pressure. Additionally, real-world data indicates that individuals with higher initial eye pressure often experience more significant pressure reductions after DSLT treatment. This suggests DSLT could be particularly beneficial for those with pseudoexfoliative glaucoma, where eye pressure is a major concern.12678

Are You a Good Fit for This Trial?

This trial is for adults with pseudoexfoliation glaucoma, a specific eye condition. Participants should have an open angle in their eye, not previously treated or able to stop current treatments, and must have relatively good vision (20/40 or better) and be capable of completing visual field tests.

Inclusion Criteria

* Participants must have a best correct visual acuity of 20/40 or better in the study eye(s), be able to undertake a reliable Humphrey visual field (HVF) (defined as fixation losses, false positives and false negatives less than 33%), and must have field loss no worse than -20 dB in treatment eye
I have been diagnosed with pseudoexfoliation glaucoma and have optic nerve damage.
* Open iridocorneal angle by gonioscopy, defined as a Shafer Grade II or greater
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Direct SLT (DSLT) treatment for pseudoexfoliative glaucoma

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Direct Selective Laser Trabeculoplasty

Trial Overview

The study is testing Direct Selective Laser Trabeculoplasty (DSLT), a laser treatment for lowering eye pressure in patients with pseudoexfoliation glaucoma. It's a forward-looking study across multiple centers where all participants receive the same intervention.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treated GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vance Thompson Vision

Lead Sponsor

Trials
11
Recruited
300+

Citations

Real-world outcomes of selective laser trabeculoplasty ... - PMC

Pearson correlation analysis revealed a moderate correlation (r = -0.4021, p < 0.001) between higher baseline IOP and greater IOP reduction.

The Safety and Efficacy of Direct SLT in Pseudoexfoliation ...

A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.

Predictors of Selective Laser Trabeculoplasty Efficacy ...

Patients were randomized to one of four SLT variants, differing in treatment extent (180° or 360°) and laser power (standard or high).

Predictors of Selective Laser Trabeculoplasty Efficacy

Patients were randomized to one of 4 SLT variants, differing in treatment extent (180° or 360°), and laser power (standard or high).

Short-term results of direct laser trabeculoplasty (DSLT) in ...

The LiGHT trial reported that SLT is a safe and effective technique as a first-line treatment for open angle glaucoma and ocular hypertension.

What is the long-term efficacy and safety of selective laser ...

Primary outcomes included long-term IOP reduction and SLT failure rates. Secondary outcomes included medication use, visual field changes, and adverse events.

An Early Look at the New DSLT Technology

The next step in selective laser trabeculoplasty recently hit the market. Experts discuss what is and isn't yet known about direct laser ...

Full article: Long-term safety and efficacy of selective laser ...

Purpose. To investigate the safety and efficacy of selective laser trabeculoplasty (SLT) to reduce intraocular pressure (IOP) in patients with ...