Direct selective laser trabeculoplasty to lower eye pressure in untreated open-angle glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study enrolling adults with newly diagnosed, untreated primary open-angle glaucoma or ocular hypertension to receive direct selective laser trabeculoplasty (DSLT) as first-line therapy. Participants will undergo DSLT and return for scheduled eye exams with intraocular pressure (IOP) measurements to determine whether IOP is reduced by greater than 20% at six months without postoperative glaucoma medications. The study is non-randomized and excludes patients with prior glaucoma treatments so the effect of DSLT can be observed without confounding therapies. Investigators will also record safety outcomes and whether patients require additional medications or procedures during follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shafer Vision Institute
  Plymouth Meeting, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Brian Shafer, MD
• Email: brian.shafer@shafervision.com
• Phone: 2672102169

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.