DSLT in Normal Tension Glaucoma (NTG) Asian Eyes

NCT07300852 | Not Yet Recruiting FDA Device

• 1 other identifier: NTG_DSLT-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

DSLT; Direct Selective Laser Trabeculoplasty; NTG; Glaucoma; Normal Tension Glaucoma; BELKIN Vision Eagle; Glaucoma laser treatment; Asian glaucoma; Intraocular pressure; SLT alternative; Glaucoma medications reduction

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP)

  Absolute change in washed-out intraocular pressure (IOP) at 12 months compared to washed-out baseline IOP. Following a 6-week washout at baseline and again at month 11, IOP will be measured using standard tonometry to assess the effect of Direct Selective Laser Trabeculoplasty (DSLT) on pressure reduction.

  12 months post procedure

Secondary Outcomes (2)

• Number of Glaucoma Medications Reduced

  12 months post-procedure

• Proportion of Patients Who Are Medication-Free

  12 months post-procedure

Study Arms (1)

DSLT Treatment Arm

EXPERIMENTAL

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.

Device: Direct Selective Laser Trabeculoplasty (DSLT)

Interventions

Direct Selective Laser Trabeculoplasty (DSLT) DEVICE

Direct Selective Laser Trabeculoplasty (DSLT) is a non-contact laser procedure that delivers energy to the trabecular meshwork without the need for a gonioscopy lens. The BELKIN Vision Eagle device automatically aligns and applies laser pulses to lower intraocular pressure in subjects with normal tension glaucoma. All participants receive a single DSLT treatment followed by routine post-procedure evaluations including IOP checks, visual field testing, and OCT imaging.

Also known as: BELKIN Vision Eagle, Non-contact SLT, DSLT Laser Treatment, Direct Selective Laser Trabeculoplasty

DSLT Treatment Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ngoc Nguyen Inc.: lead
• Alcon Research: collaborator

Study Sites (1)

Ngoc Nguyen M.D.

San Jose, California, 95116, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Central Study Contacts

Ngoc Nguyen, M.D.

CONTACT

4082723706; ngocyu@hotmail.com

Lauren Nguyen

CONTACT

4086092569; laurenhtnguyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)