NCT06506669

Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.

Detailed description

This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.

Conditions

• Cataract
• Bilateral Senile Cataract
• Anesthesia
• Patient Satisfaction

Interventions

Type	Name	Description
PROCEDURE	Oral sedation	Oral medication for anxiolysis administered in the preoperative setting
PROCEDURE	Placebo	A placebo pill with no active ingredients administered in the preoperative setting

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-05-06
• Completion: 2025-08-01
• First posted: 2024-07-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States