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NCT Number: NCT07300852

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 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.

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Key information

Conditions

Normal Tension Glaucoma (NTG) Eye Diseases Glaucoma Glaucoma, Open Angle Glaucoma, Open-Angle Low Tension Glaucoma Ocular Hypertension Open Angle Glaucoma (OAG) Optic Nerve Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BELKIN Vision Eagle, Non-contact SLT, DSLT Laser Treatment, Direct Selective Laser Trabeculoplasty

Primary outcomes

  1. Change in Intraocular Pressure (IOP)

    Time frame: 12 months post procedure

    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.

Secondary outcomes

  1. Number of Glaucoma Medications Reduced

    Time frame: 12 months post-procedure

    Change in the number of topical glaucoma medications required to control intraocular pressure at 11 months compared to baseline, to evaluate whether DSLT decreases medication burden.

  2. Proportion of Patients Who Are Medication-Free

    Time frame: 12 months post-procedure

    Proportion of participants who require zero topical glaucoma medications at 11 months after DSLT treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Nguyen

CONTACT

[email protected]

4086092569

Ngoc Nguyen, M.D.

CONTACT

[email protected]

4082723706

Sponsors and collaborators

Lead sponsor

Ngoc Nguyen Inc.

Other

Collaborators

  • Alcon Research

Registry information

Official study title

The Effectiveness of DSLT in Asian Normal Tension Glaucoma Patients

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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