Study Results
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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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-01
2028-03-31
Brief Summary
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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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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Ngoc Nguyen Inc.
OTHER
Responsible Party
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Ngoc Nguyen M.D.
Principal Investigator
Locations
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Ngoc Nguyen M.D.
San Jose, California, United States
Countries
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Central Contacts
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Facility Contacts
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Lauren Nguyen
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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NTG_DSLT-001
Identifier Type: -
Identifier Source: org_study_id