Near Normal Intraocular Pressure Cataract Surgery In Patients With Diabetic Retinopathy Using Active Anterior Chamber Pressure Sensing And Regulation – A Randomized Controlled Comparative Clinical Trial

To evaluate if cataract surgery with near normal intraocular pressure (IOP) using the Alcon Centurion Vision System with Active Sentry can reduce surgical trauma in patients with diabetic retinopathy compared to standard IOP settings.

Single-center, prospective, randomized, controlled clinical trial at the Department of Ophthalmology, Medical University of Innsbruck, Austria.

72 patients with bilateral cataract and non-proliferative diabetic retinopathy were randomized in a 1:1 ratio to undergo same-session sequential bilateral microincision cataract surgery using the Centurion Vision System with Active Sentry. In one group, the worse eye was operated on with an IOP set at 28mmHg, while the better eye was set at 50mmHg. In the second group, the worse eye was set to an IOP of 50mmHg and the better eye to 28mmHg. The primary outcome was the difference in postoperative anterior chamber flare (ACF) between the two groups, measured at day 1 and day 7 postoperatively. Secondary outcomes included changes in visual acuity, corneal and macular thickness, retinal nerve fiber layer thickness, endothelial cell density.

Patient recruitment for this study is ongoing and 18 patients have been included to date. Preliminary study results of 30 cases (60 eyes) will be available by September 2025.

This study examines whether near-normal IOP cataract surgery can reduce surgical trauma or improve outcomes in diabetic patients. The ability to safely perform cataract surgery at a reduced IOP, facilitated by Active Sentry anterior chamber stabilization, may offer a valuable risk-minimization strategy for all patients undergoing cataract surgery.