Study of Remimazolam for Cataract Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract Surgery Anesthesia
• Intervention / Treatment: Drug: Arm 1 Cataract Surgery performed with remimazolam as sedative; Drug: Arm 2 Cataract Surgery performed with standard of care sedative

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vikranth R. Chinthareddy, BA; Phone Number: 617-573-3380; Email: vchinthareddy@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary
      • Contact: Vikranth R. Chinthareddy, BA; Phone Number: 617-573-3380; Email: vchinthareddy@meei.harvard.edu
      • Principal Investigator: Fred E. Shapiro, DO, FASA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 does not speak or read English

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Drug: Arm 2 Cataract Surgery performed with standard of care sedative; Standard of care sedative will be used during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of sedation-related adverse events	The number of sedation-related adverse events from the time sedation is administered at the start of surgery through up to one week post-surgery.	Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The severity of sedation-related adverse events	The severity (mild, moderate or severe) of sedation-related adverse events	Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The duration of sedation-related adverse events	The duration, in minutes, hours, or days of sedation-related adverse events	Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
Time that subject remains in the post anesthesia care unit (PACU)	Length of time in minutes that subject remains in the post anesthesia care unit (PACU) until he or she meets criteria for discharge. We are recruiting subjects whose cataract surgery is deemed uncomplicated and anticipated to last no more than 30 minutes. This is required to use remimazolam on label. We anticipate that subjects would be in the PACU for less than sixty minutes, but that the use of remimazolam will lead to discharge in less than 30 minutes.	Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects' scores using the Aldrete Postanesthetic Recovery assessment	Subjects' scores on repeated assessments made by staff while they are in the PACU using the Aldrete Postanesthetic Recovery Score system. The Aldrete Scoring System consists of 5 clinically relevant parameters reflecting physiological recovery from anesthesia: muscle activity, respiration, circulation, consciousness, and oxygenation. Each category is assigned a score of 0, 1, or 2, with a maximum possible total score of 10.	During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on the Richmond Agitation Sedation Scale (RASS)	Subjects' scores on repeated assessments made by staff while they are in the PACU using the Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) was developed to assess the level of alertness and agitated behavior in patients who have received sedation. It is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation and levels +1 to +4 describe increasing levels of agitation.	During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on patient satisfaction questionnaires	Subjects will be asked to complete a questionnaire regarding their satisfaction with the sedation they received and their post-surgical recovery	Questionnaire will be completed the day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Indirect costs	We aim to compare subjects' indirect costs associated with post-surgical care i.e. time spent in the PACU prior to discharge post-surgery, and the time clinicians spend providing follow-up care related to the surgery in the weeks following discharge. We would like to compare standard of care vs. remimazolam.	1 year

Collaborators and Investigators

• Sponsor: Fred E, Shapiro
• Collaborators: Massachusetts Eye and Ear Infirmary; Eagle Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cataract surgery; remimazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Hypnotics and Sedatives; remimazolam
• Other Study ID Numbers: 2025P002034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results will be published in a medical journal.
• IPD Sharing Time Frame: Study consent form will be added to this record after the documents are IRB approved. Data collection will be complete in 2027. Data will be analyzed in 2027 and the report will be published in 2028. We do not anticipate making the full data set available to others.
• IPD Sharing Access Criteria: The consent form will be available to members of the public that read this record on Clinicaltrials.gov.
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No