A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Pressure (IOP) Reduction Without Medications at 6 Months in Naive, Untreated Glaucoma Patients
Launched by BRIAN SHAFER · Jul 14, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new laser treatment called Direct Selective Laser Trabeculoplasty (DSLT) to see if it can safely lower eye pressure by more than 20% in people who have just been diagnosed with certain types of glaucoma or high eye pressure but have not yet started any treatment. Elevated eye pressure is the main cause of glaucoma, a condition that can slowly damage vision if left untreated. Unlike typical treatments that require daily eye drops, this laser procedure aims to reduce eye pressure without the need for medications afterward.
Adults aged 18 and older who have recently been diagnosed with early-stage open-angle glaucoma or similar conditions, and who have never used glaucoma medications or had eye surgery for glaucoma, may be eligible to join the study. Participants will receive the laser treatment and be monitored over six months to see how well it lowers their eye pressure and if they can avoid using eye drops. The study focuses on people with uncomplicated glaucoma to clearly understand how effective and safe this new laser approach is as a first treatment option. This research could offer a simpler, medication-free option for managing glaucoma early on, potentially improving quality of life and long-term eye health.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Adults aged 18 years or older:
- • Participants must be adults, aged 18 years or older, to ensure they are capable of providing informed consent and to focus on adult-onset glaucoma. This age threshold allows the study to target a population where open-angle glaucoma typically manifests, avoiding potential variations in outcomes that might arise in younger populations with different types of ocular conditions.
- Diagnosis of naive, untreated open-angle glaucoma or similar conditions:
- • The study is restricted to individuals who have been newly diagnosed with primary open-angle glaucoma and have not yet received any form of treatment, either pharmacological or surgical. This ensures that the effects of DSLT (Direct Selective Laser Trabeculoplasty) are evaluated without the confounding influence of prior treatments.
- • Other similar conditions may include ocular hypertension or other early-stage glaucomatous conditions where IOP reduction is indicated (ie: pigment dispersion syndrome/glaucoma and pseudoexfoliation). This broadens the inclusion slightly to capture patients with conditions that have a similar disease mechanism and treatment goal, without including those with more complex or mixed forms of glaucoma.
- Exclusion Criteria:
- Previous glaucoma surgeries/interventions:
- • Patients who have undergone prior glaucoma-related surgeries (e.g., trabeculectomy, laser trabeculoplasty, or shunt procedures) or received other significant glaucoma interventions (such as long-term glaucoma medication use) are excluded. This criterion ensures the study evaluates the effect of DSLT in a treatment-naive population. Prior surgeries or interventions could bias the results by introducing variability in eye physiology, making it difficult to attribute outcomes solely to DSLT.
- Secondary glaucoma or other significant ocular conditions:
- • Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases, are excluded. These conditions often have different pathophysiological mechanisms, which could lead to varied responses to DSLT.
- • Other significant ocular conditions that could interfere with the study include 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. Excluding these conditions ensures a clearer evaluation of DSLT's effects on open-angle glaucoma without interference from unrelated ocular abnormalities.
- • 3. Patients who are unable to fixate their head and/or eyes, such as patients suffering from uncontrolled nystagmus, tremors, or similar conditions.
- • 4. Patients with a pupil that cannot constrict to a diameter of 4 mm or less.
- • In summary, these criteria focus on a specific and controlled population of treatment-naive glaucoma patients to provide a clean evaluation of the effectiveness and safety of DSLT, while excluding individuals whose prior treatments or other conditions could skew the results.
About Brian Shafer
Brian Shafer is a clinical trial sponsor with expertise in overseeing and managing research studies aimed at advancing medical knowledge and improving patient care. Committed to maintaining high standards of regulatory compliance and ethical conduct, Brian Shafer collaborates closely with research teams to ensure the successful execution of clinical trials from initiation through completion.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Plymouth Meeting, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported