Normal Tension Glaucoma (NTG), Glaucoma, Open Angle Glaucoma (OAG), Glaucoma, Open Angle
Conditions
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
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.
Interventions
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.
Sponsors
Alcon Research
Ngoc Nguyen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Glaucoma Medications Reduced | 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. |
| Proportion of Patients Who Are Medication-Free | 12 months post-procedure | Proportion of participants who require zero topical glaucoma medications at 11 months after DSLT treatment. |
Countries
United States
Contacts
Primary ContactNgoc Nguyen, M.D.
Backup ContactLauren Nguyen
Outcome results
None listed