Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects. In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups. The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.

NCT Number	NCT07347886
Lead Sponsor	Istanbul University - Cerrahpasa
Conditions	Cataract
Enrollment	120 participants
Start Date	2026-01
Primary Completion	2026-07 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-01-16