NCT07325227

Study of Remimazolam for Cataract Surgery

Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fred E, Shapiro · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time.

Detailed description

Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Remimazolam is a rapid onset/offset benzodiazepine, designed to be rapidly metabolized without active metabolites reduce the changes in cognitive function known to occur after even a brief exposure to a sedative. This study will use remimazolam on-label to sedate patients having cataract surgeries that take less than 30 minutes to perform. The investigator is studying the use of remimazolam in cataract surgery because the investigator think it will improve patient safety by shortening post-surgery cognitive recovery time and decreasing the number of sedation-related complications.

Conditions

• Cataract Surgery Anesthesia

Interventions

Type	Name	Description
DRUG	Arm 1 Cataract Surgery performed with remimazolam as sedative	Sedation will be remimazolam in one eye and the standard of care in the other eye.
DRUG	Arm 2 Cataract Surgery performed with standard of care sedative	Standard of care sedative will be used during surgery.

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-01-31
• Completion: 2027-12-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study