Sheridan

Researchers are evaluating whether low energy selective laser trabeculoplasty SLT is as effective as standard energy SLT for treating glaucoma and ocular hypertension. The study aims to determine if repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting for the effects of standard SLT to wear off before repeating it. This is a phase 3 randomized clinical trial sponsored by the University of Pittsburgh. Participants initially receive either standard energy SLT, where energy levels are adjusted to produce champagne bubbles every 2nd or 3rd spot during a 360-degree treatment, or low energy SLT, delivering 100 spots at 0.4 mJ per spot with energy adjustments based on bubble formation. After 12 months, eligible participants are randomized to either annual repeat low energy SLT or as-needed repeat standard energy SLT. One treatment arm was discontinued following an interim analysis. Throughout the study, participants are monitored at regular intervals up to 48 months to track outcomes such as 12-month and 48-month treatment survival, mean intraocular pressure IOP at multiple time points, and occurrence of IOP spikes. The study involves assessments of eye pressure and glaucoma progression, with follow-up visits scheduled to observe long-term effects and safety. Total participation may extend up to four years, including repeated evaluations and treatments.

This clinical trial focuses on patients aged 45 and older with refractory open-angle glaucoma, a condition where the pressure inside the eye remains high despite medical and surgical treatments. The study aims to evaluate the safety and effectiveness of the VisiPlate Aqueous Shunt, a device designed to lower intraocular pressure IOP in these patients. This prospective, multicenter, single-arm, open-label trial is sponsored by Avisi Technologies Inc. and seeks to provide new options for those with limited treatment success. Participants will receive the VisiPlate Glaucoma Implant, a micro-shunt device placed in the eye to reduce IOP. This is a single treatment arm study without a comparison group or placebo. The device is implanted to help control eye pressure in patients with specific types of glaucoma, including open-angle, pseudoexfoliative, or pigmentary glaucoma. The study involves monitoring the devices impact on IOP over a 12-month period. Throughout the study, participants will undergo regular evaluations to measure intraocular pressure and assess any changes in their eye health. The primary outcome is the proportion of participants achieving at least a 20% reduction in mean diurnal IOP after 12 months. Secondary outcomes include the percentage change in IOP during this time. Safety and effectiveness will be closely monitored, with follow-up visits to track progress and address any complications. The total duration of participation is at least one year following device implantation.

Researchers are evaluating a bilingual digital shared decision-making tool called WePrEP, designed to improve communication between transgender women and their HIV pre-exposure prophylaxis PrEP service providers. The study focuses on helping transgender women choose the most suitable PrEP method, either oral or injectable cabotegravir CAB-LA, by addressing their unique concerns and enhancing adherence. This tool aims to support diverse English- and Spanish-speaking transgender women and their providers in selecting the best PrEP option for each individual. The study involves a randomized controlled trial with 69 transgender women assigned in a 21 ratio to either use WePrEP with their providers or receive standard care explanations based on CDC guidelines. Providers in the intervention group will use WePrEP on tablets to present key information and guide discussions about PrEP options and adherence strategies. Control group providers will give standard PrEP explanations without the tool. Providers will use WePrEP with multiple participants to provide feedback during the study. Participants will undergo assessments at enrollment and follow-up visits, including measuring feasibility and acceptability of WePrEP, as well as preliminary impact measures such as PrEP uptake, serum concentrations, and adherence behavior. Patient-provider communication, satisfaction, engagement, and shared decision-making will also be evaluated using validated scales and qualitative methods. The trial runs from early 2025 through 2027, with ongoing monitoring of outcomes relevant to PrEP use in transgender women.