DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Direct Selective Laser Trabeculoplasty (DSLT).
- Who it may be relevant to
- Registry conditions: Normal Tension Glaucoma (NTG), Glaucoma, Open Angle Glaucoma (OAG), Glaucoma, Open Angle. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effectiveness of DSLT in Asian Normal Tension Glaucoma Patients
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Change in Intraocular Pressure (IOP) [Time frame: 12 months post procedure]
Secondary outcome measures (2)
- Number of Glaucoma Medications Reduced [Time frame: 12 months post-procedure]
- Proportion of Patients Who Are Medication-Free [Time frame: 12 months post-procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ngoc Nguyen M.D. — San Jose
Identifiers
NCT: NCT07300852 · NTG_DSLT-001