Study of iStent Infinite and iDose TR Surgery for Reducing Eye Pressure in Moderate to Severe Open Angle Glaucoma Patients Who Have Not Responded to Medication

What this Trial Is About

Researchers are evaluating the effectiveness of combining the minimally invasive iStent infinite trabecular micro-bypass system and the iDose TR Travoprost intracameral Implant in patients with moderate to severe open angle glaucoma that is not controlled by medication. This study aims to determine if this combination can serve as a safe and effective alternative to traditional filtering surgery for reducing intraocular pressure in these patients. The investigation focuses on measuring changes in eye pressure, medication use, additional surgeries, and adverse events. Participants will undergo surgery that uses the combined iStent infinite device and iDose TR drug implant to reduce eye pressure. This approach involves implanting both a micro-bypass stent and a drug depot into the eye during the procedure. The study does not include a comparison or placebo group all participants will receive this combined treatment. Researchers will monitor participants over time to assess outcomes and safety. Throughout the study, participants will have their intraocular pressure measured, including diurnal pressure changes, and their use of glaucoma medications recorded. The need for further incisional glaucoma surgery and any side effects will also be tracked. Visual acuity and visual field measurements will be assessed to evaluate eye health. The main outcome is the reduction in intraocular pressure at 12 months compared to baseline. Participants progress will be followed closely to ensure safety and effectiveness during the trial period.

Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma