Laser Treatments for Glaucoma

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two laser treatments for glaucoma, a condition where increased eye pressure can lead to vision loss. Both treatments aim to lower eye pressure, but Direct Selective Laser Trabeculoplasty (DSLT) is a newer method that might offer more comfort. Participants will be randomly assigned to receive either the new DSLT or the traditional method and will be monitored for a year. This study is suitable for adults with open-angle glaucoma or ocular hypertension who can attend follow-up appointments. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand how it benefits more patients.

Do I need to stop my current medications for the glaucoma laser treatment trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these laser treatments?

Research shows that both Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) safely lower eye pressure in people with glaucoma. Although DSLT is a newer method, it is just as safe as SLT. One study found that DSLT effectively reduces eye pressure in people with primary open-angle glaucoma.

Both DSLT and SLT have FDA approval, indicating they have undergone safety testing in earlier studies. Reports from patients who have used these treatments indicate they are well-tolerated, with no new or unexpected side effects. While DSLT is relatively new, it has shown promise as a safe option alongside the more established SLT.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Direct Selective Laser Trabeculoplasty (SLT) for glaucoma because it offers a more targeted approach compared to traditional treatments. Unlike standard options that rely on broader laser application, Direct SLT precisely targets specific areas of the eye, potentially leading to more efficient fluid drainage and lower eye pressure. This precision could enhance treatment effectiveness while reducing side effects, making it a promising advancement in glaucoma care.

What is the effectiveness track record for these laser treatments for glaucoma?

This trial will compare Direct Selective Laser Trabeculoplasty (DSLT) with Traditional Selective Laser Trabeculoplasty (SLT) for treating glaucoma. Research has shown that both DSLT and SLT effectively lower eye pressure, which is crucial for treating glaucoma. One study found that after 12 months, both treatments reduced eye pressure by about 3.2 mm Hg. Early results suggest that DSLT, which participants in one arm of this trial will receive, is not only effective but also safe for patients with primary open-angle glaucoma. Meanwhile, SLT, which participants in another arm will receive, has proven over the years to effectively lower eye pressure and is a standard treatment for glaucoma. DSLT, as a newer method, seems to offer similar benefits and may be more comfortable for patients.24678

Who Is on the Research Team?

JA

Jella An, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT), who have a clear view of the eye's drainage angle. Participants must be able to consent and attend follow-up appointments.

Inclusion Criteria

Gonioscopically open angle (visible scleral spur 360°)
I am 18 years old or older.
I have been diagnosed with open-angle glaucoma or high eye pressure.
See 1 more

Exclusion Criteria

IOP >35 mmHg despite therapy
I have had eye surgery in the last 6 months.
I have an eye condition that affects laser treatments or pressure tests.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Direct Selective Laser Trabeculoplasty (DSLT) or Selective Laser Trabeculoplasty (SLT) to lower eye pressure

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Direct Selective laser Trabeculoplasty

Trial Overview

The study compares two FDA-approved laser treatments for glaucoma: Direct Selective Laser Trabeculoplasty (DSLT) and standard Selective Laser Trabeculoplasty (SLT). It aims to see if DSLT is as good as SLT in lowering eye pressure over a year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Direct Selective Laser TrabeculoplastyExperimental Treatment1 Intervention
Group II: Traditional Selective Laser TrabeculoplastyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

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

SLT is an effective primary treatment for reducing IOP in Nigerian patients with open-angle glaucoma, particularly those with higher baseline ...

Direct SLT May Be an Alternative Treatment Option to ...

At 6 months, the DSLT group had a mean 5.5 mm Hg (20.6%) IOP reduction, while the SLT group had a mean 6.2 mm Hg (23.6%) reduction. While the ...

Direct Selective Laser Trabeculoplasty At 6 Months Falls ...

At 12 months, of 161 eyes, 77 with SLT displayed a 3.2 (±0.4) mm Hg reduction. Similarly, 84 having DSLT also lessened by 3.2 (±0.4) mm Hg (P <.

Five-year outcomes of selective laser trabeculoplasty

Studies have shown the efficacy of selective laser trabeculoplasty (SLT) to lower intraocular pressure (IOP) as adjuvant therapy during short-term follow-up.

First results of direct selective laser trabeculoplasty for the ...

Data from this study suggest DSLT to be a safe and effective IOP-lowering procedure both in primary open-angle glaucoma (POAG) and in primary ...

Real World Comparison of Direct Selective Laser ... - PMC

Results: The survival rates in the DSLT vs. SLT group were 81% vs. 78%, 44% vs. 62%, and 37% vs. 43% at 3, 6, and ...

Direct vs Standard SLT for Glaucoma: A Noninferiority Trial

This study compares two FDA-approved laser treatments for glaucoma: Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser ...

Randomized Noninferiority Trial of Direct Selective Laser ...

Main Outcome Measures: Difference between DSLT and SLT in mean IOP change from baseline to 6 months. (noninferiority margin, e1.95 mmHg).