Direct vs Standard SLT for Glaucoma: A Noninferiority Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
This study compares two FDA-approved laser treatments for glaucoma: Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT). Both procedures aim to lower eye pressure and prevent vision loss. DSLT is a newer, non-contact technique that may improve comfort and efficiency. Participants will be randomly assigned to receive either DSLT or SLT and followed for 12 months to assess eye pressure, safety, and treatment outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Diagnosis of OAG (including exfoliative or pigmentary) or OHT
Gonioscopically open angle (visible scleral spur 360°)
Ability to consent and comply with follow-up
Disqualifiers
Angle-closure or secondary glaucomas
IOP >35 mmHg despite therapy
Corneal pathology interfering with laser or IOP measurement
Recent ocular surgery (<6 months)
Trial design
Design model
Parallel
Treatments tested in this trial
Direct Selective laser Trabeculoplasty
DeviceThe Direct Selective Laser Trabeculoplasty is a non-contact laser designed to manage IOP in patients with glaucoma. The traditional SLT required a gonioscopy lens to be placed over the patient's eyes to direct the laser towards the trabecular meshwork.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Direct Selective Laser TrabeculoplastyExperimental treatment 1 intervention
Group B: Traditional Selective Laser TrabeculoplastyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Intraocular Pressure at 12 months from baseline
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov