Study of Remimazolam for Cataract Surgery

NCT ID: NCT07325227

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2027-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Arm 1 Cataract Surgery performed with remimazolam as sedative

Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation will be remimazolam in one eye and the standard of care in the other eye. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.

Group Type: EXPERIMENTAL

Arm 1 Cataract Surgery performed with remimazolam as sedative

Intervention Type: DRUG

Sedation will be remimazolam in one eye and the standard of care in the other eye.

Arm 2 Cataract Surgery performed with a standard of care sedative

Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation in this arm will be the standard of care. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery.

Group Type: PLACEBO_COMPARATOR

Arm 2 Cataract Surgery performed with standard of care sedative

Intervention Type: DRUG

Standard of care sedative will be used during surgery.

Interventions

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.

Intervention Type: DRUG

Arm 2 Cataract Surgery performed with standard of care sedative

Standard of care sedative will be used during surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is planning to have cataract surgery in both eyes
• The surgeon estimates that each cataract surgery are estimated to take less than 30 minutes
• Subject is aged 55 to 90 years old
• Surgeries will take place on the main campus of Mass Eye and Ear at 243 Charles St., Boston for at least the first year. In the future, surgeries may also occur at Mass Eye and Ear Longwood Surgical Ambulatory Care Center.
• Subject is able to understand the consent form and sign the consent
• ASA 1-3 (possible breakdown numbers of 5, 10, 10, 5)

Exclusion Criteria

• Subject has a history of difficulty with sedation during procedures
• The surgeon estimates that one of the planned cataract surgeries is estimated to take longer than 30 minutes
• Subject uses concomitant home narcotic or anxiolytic
• Subject uses O2
• Subject has a history of cognitive decline
• A history of severe hepatic impairment

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eagle Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: collaborator

Fred E, Shapiro

OTHER

Sponsor Role: lead

Responsible Party

Fred E, Shapiro

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Vikranth R. Chinthareddy, BA

Role: CONTACT

vchinthareddy@meei.harvard.edu

617-573-3380

Facility Contacts

Vikranth R. Chinthareddy, BA

Role: primary

vchinthareddy@meei.harvard.edu

617-573-3380

References

Alqudah A, Al-Dwairi R, Sharayah A, Al-Qudah NS, Almustafa YS, Al-Qudah A, Alharahsheh D, Al Awam RK, Al-Qudah H, Aleshawi A. Second Eye Syndrome: Patients' Perspectives Regarding First Eye versus Second Eye Phacoemulsification and Intraocular Lens Implantation Surgery. Patient Prefer Adherence. 2025 Jul 19;19:2081-2094. doi: 10.2147/PPA.S534166. eCollection 2025.

Reference Type: BACKGROUND

PMID: 40704218 (View on PubMed)

Other Identifiers

2025P002034

Identifier Type: -

Identifier Source: org_study_id