Status:
RECRUITING
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
Lead Sponsor:
Brian Shafer
Conditions:
Primary Open Angle Glaucoma
Glaucoma
Eligibility:
All Genders
18+ years
Brief Summary
Background Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07076303
Start Date
March 11 2002
End Date
June 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, United States, 19462