Laser Treatment for Normal Tension Glaucoma

NN
LN
Overseen ByLauren Nguyen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ngoc Nguyen Inc.
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 laser treatment called Direct Selective Laser Trabeculoplasty (DSLT) to determine if it can lower eye pressure and reduce medication needs in people with normal tension glaucoma (NTG). NTG is a type of glaucoma where optic nerve damage occurs despite not having very high eye pressure. The trial seeks Asian participants diagnosed with NTG who currently manage it with up to three medications. Participants will attend regular check-ups and undergo eye tests to monitor progress after receiving the laser treatment. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for NTG.

Will I have to stop taking my current medications?

The trial requires that participants who are on 1-3 medications for normal tension glaucoma must be safe to stop taking them (washout period) before participating.

What prior data suggests that this laser treatment is safe for normal tension glaucoma?

Research shows that Direct Selective Laser Trabeculoplasty (DSLT) is generally easy for patients to handle. Studies have found that DSLT reduces eye pressure in people with glaucoma without major safety issues. It serves as a safe and effective alternative to traditional medications.

DSLT resembles another procedure called Selective Laser Trabeculoplasty (SLT), but DSLT does not require a contact lens on the eye, potentially increasing comfort. Reports of significant side effects are lacking, suggesting that the treatment is safe for most people.

For those considering joining this trial, it is reassuring that other studies have demonstrated DSLT to be a safe procedure for similar conditions.12345

Why are researchers excited about this trial?

Direct Selective Laser Trabeculoplasty (DSLT) is unique because it delivers laser energy without making direct contact with the eye, unlike traditional laser treatments that require a contact lens. This non-contact approach potentially reduces discomfort and risk during the procedure. Additionally, DSLT specifically targets the trabecular meshwork to lower intraocular pressure, which is crucial for managing normal tension glaucoma. Researchers are excited about DSLT because it could offer a more comfortable and efficient way to treat this condition compared to current options like medications or conventional laser therapies.

What evidence suggests that this laser treatment is effective for normal tension glaucoma?

Research shows that Direct Selective Laser Trabeculoplasty (DSLT), which participants in this trial will receive, can effectively lower eye pressure in people with glaucoma. For those with normal tension glaucoma (NTG), studies indicate that eye pressure can drop by 6.9% to 35.9% after one year, although the decrease is usually smaller in NTG compared to other types of glaucoma. The LIGHT trial found that a similar treatment, selective laser trabeculoplasty (SLT), worked about 75% of the time as a first treatment. In real-world situations, an average drop in eye pressure of 4.0 mmHg has been observed. This suggests that DSLT could be a promising way to manage eye pressure without needing contact lenses during the procedure.14678

Are You a Good Fit for This Trial?

This trial is for Asian individuals with normal tension glaucoma, a condition where the eye's pressure is normal but there's still damage to the optic nerve. Participants should be willing to undergo routine follow-ups and tests like OCT imaging and visual field assessments after receiving laser treatment.

Inclusion Criteria

Central corneal thickness (CCT) 450-600µm
Asian descent
All participants are able to provide written informed consent before participation
See 6 more

Exclusion Criteria

I had eye surgery over a year ago, except for vision correction.
I expect to have cataract surgery during the study.
I have glaucoma, but not normal-tension glaucoma.
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 Direct Selective Laser Trabeculoplasty (DSLT) using the BELKIN Vision Eagle device

1 day
1 visit (in-person)

Follow-up

Participants attend routine follow-up visits with their eye surgeon and undergo glaucoma testing such as OCT imaging and visual field tests

12 months
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Direct Selective Laser Trabeculoplasty (DSLT)

Trial Overview

The study is testing Direct Selective Laser Trabeculoplasty (DSLT), a type of laser therapy, to see if it can lower eye pressure and reduce the need for medication in patients with normal tension glaucoma without causing significant discomfort or side effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DSLT Treatment ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ngoc Nguyen Inc.

Lead Sponsor

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

Real-world outcomes of selective laser trabeculoplasty

71 eyes of 44 patients were included in this study. There was a mean reduction in IOP of 4.0 mmHg (SD 3.6), from 19.1 mmHg (SD 3.6) at baseline ...

Two-Year Outcome: SLT for Normal-Tension Glaucoma (Japan)

The mean IOP reduction after SLT was reported to range from 6.9% to 35.9% at one year, with lower efficacy observed in normal-tension glaucoma (NTG) and greater ...

Direct Selective Laser Trabeculoplasty

The Laser in Glaucoma and Ocular Hypertension (LIGHT) trial demonstrated that SLT, when performed as primary therapy, was effective 75% of the time, ...

Randomized Noninferiority Trial of Direct Selective Laser ...

Graph showing the primary effectiveness outcome: 6-month mean intraocular pressure (IOP) change from baseline (6-month modified per- protocol ...

DSLT in Normal Tension Glaucoma (NTG) Asian Eyes

The goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian ...

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 ...

Non-Contact Laser Therapy for Glaucoma: A Review of ...

Selective Laser Trabeculoplasty (SLT) has emerged as a safe, effective, and repeatable alternative to medical therapy for patients with open-angle glaucoma (OAG) ...

DSLT: The Future of Glaucoma Treatment

Unlike conventional SLT (Selective Laser Trabeculoplasty), which uses a contact lens on the eye to target the drainage angle with a slit lamp, ...