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Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated With Selective Laser Trabeculoplasty (SLT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe a laser treatment called DSLT is and how well it lowers eye pressure after 6 months. It is for adults with high eye pressure or primary open-angle glaucoma who have already had a laser treatment called SLT. Everyone gets DSLT, and patients using glaucoma eye drops will pause them for a short time as part of the study.

This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients. Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT. The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment. The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old and scheduled to have DSLT in one eye.
  • You have high eye pressure or primary open-angle glaucoma, a type of glaucoma.
  • You have had SLT laser treatment before.
  • Your eye pressure is 18 to 32 mm Hg without eye pressure medicine or after a planned pause in that medicine.

Who can't join

  • You use eye pressure medicine but cannot complete the required pause before treatment.
  • You have had certain glaucoma surgeries or procedures. The listing also excludes past laser treatment, even though it requires past SLT. Ask the study team to clarify this.
  • Your earlier SLT treatment failed within 6 months of that treatment.
  • You had cataract surgery in the past 2 years.
  • You have another listed type of glaucoma, such as angle-closure glaucoma or glaucoma linked to new blood vessels, injury, or other diseases.
  • You have serious eye problems, such as advanced cataracts (cloudy lenses) or diseases of the retina (the light-sensing layer at the back of the eye).
  • The study doctor finds another condition that could make eye pressure or vision hard to assess.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * • Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye. * Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG). * Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 through 32 mm Hg. Exclusion Criteria: * • Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0) * Previous glaucoma surgeries/interventions: * Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt). * Recent SLT failures (within 6 months of initial treatment). * Patients who have undergone cataract surgery within the prior 2 years. * Secondary glaucoma: o Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases. * Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.

Study sites (1)

NY