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Recruiting NCT07408154

Direct vs Standard SLT for Glaucoma: A Noninferiority Trial

No phase Interventional Open-angle Glaucoma (OAG) Ocular Hypertension (OHT)

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.
Who it may be relevant to
Registry conditions: Open-angle Glaucoma (OAG), Ocular Hypertension (OHT). Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial Comparing Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma

Overview

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.

Interventions

  • Device Direct Selective laser Trabeculoplasty
    The 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.

Primary outcome measures

  • Change in Intraocular Pressure at 12 months from baseline [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Angle-closure or secondary glaucomas
  • IOP >35 mmHg despite therapy
  • Corneal pathology interfering with laser or IOP measurement
  • Recent ocular surgery (<6 months)
  • Contraindications to study medications or procedures
  • Cognitive impairment preventing consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MUSC — Charleston

Identifiers

NCT: NCT07408154 · Pro00148724

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗