DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNgoc Nguyen Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Direct Selective Laser Trabeculoplasty (DSLT)
DeviceDirect 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: DSLT Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Intraocular Pressure (IOP)
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.
Time frame
12 months post procedureSecondary outcomes
1
Number of Glaucoma Medications Reduced
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.
Time frame
12 months post-procedure2
Proportion of Patients Who Are Medication-Free
Proportion of participants who require zero topical glaucoma medications at 11 months after DSLT treatment.
Time frame
12 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ngoc Nguyen Inc.
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: