DSLT in Normal Tension Glaucoma (NTG) Asian Eyes

NCT ID: NCT07300852

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSLT Treatment Arm

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.

Group Type EXPERIMENTAL

Direct Selective Laser Trabeculoplasty (DSLT)

Intervention Type 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.

Interventions

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Direct Selective Laser Trabeculoplasty (DSLT)

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.

Intervention Type DEVICE

Other Intervention Names

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BELKIN Vision Eagle Non-contact SLT DSLT Laser Treatment Direct Selective Laser Trabeculoplasty

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Ngoc Nguyen Inc.

OTHER

Sponsor Role lead

Responsible Party

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Ngoc Nguyen M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ngoc Nguyen M.D.

San Jose, California, United States

Site Status

Countries

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United States

Central Contacts

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Ngoc Nguyen, M.D.

Role: CONTACT

Phone: 4082723706

Email: [email protected]

Lauren Nguyen

Role: CONTACT

Phone: 4086092569

Email: [email protected]

Facility Contacts

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Lauren Nguyen

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NTG_DSLT-001

Identifier Type: -

Identifier Source: org_study_id