DSLT in Normal Tension Glaucoma (NTG) Asian Eyes

Ngoc Nguyen Inc.

Status: Not yet enrolling

Conditions: Open Angle Glaucoma (OAG); Normal Tension Glaucoma (NTG); Glaucoma; Glaucoma, Open Angle

Treatments: Device: Direct Selective Laser Trabeculoplasty (DSLT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07300852

NTG_DSLT-001

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy of direct selective laser trabeculoplasty (DSLT) or laser treatment in Asian patients with normal tension glaucoma. The main question it aims to answer is:

Does the DSLT reduce intraocular pressure (IOP) and medication use in Asian NTG subjects? Participants will attend routine follow-up visits with their eye surgeon and glaucoma testing such as optical coherence tomography (OCT) imaging and visual field test(s) after the laser study treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asian descent
• NTG diagnosis: glaucomatous optic neuropathy in patients with IOP measurements consistently lower than 21 mmHg
• Mean deviation (MD) of the visual field between 0 to -12dB
• No significant central vision loss within 5 degrees within 5th percentile
• Age ≥20 years
• NTG patients who are medically controlled on 1-3 medications and safe to wash out or IOP is still insufficient from medications and safe to washout
• Shaffer grade II or more on 3 of the 4 quadrants
• Central corneal thickness (CCT) 450-600µm
• All participants are able to provide written informed consent before participation

Exclusion criteria

• Angle closure glaucoma or narrow angle status post laser peripheral iridotomy (LPI), or any other open angle glaucoma excluding NTG
• History of SLT within last 2 years
• History intraocular surgery including refractive surgery, except for history of cataract surgery that has been greater than 1 year
• Patients anticipating cataract surgery during the study follow-up period
• Unable to have DSLT procedure due to pre-limbal findings
• Any presence of relevant ocular diseases including retinal disease with no confirmed cure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

DSLT Treatment Arm

Experimental group

Description:

Participants will receive Direct Selective Laser Trabeculoplasty (DSLT) using the BELKIN Vision Eagle device. The procedure is performed without a contact lens and delivers non-contact laser energy to the trabecular meshwork to lower intraocular pressure. All participants undergo standard pre- and post-procedure evaluations, including IOP measurements, visual field testing, and OCT imaging.

Treatment:

Device: Direct Selective Laser Trabeculoplasty (DSLT)