Study of Remimazolam for Cataract Surgery

NCT07325227 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P002034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery Anesthesia

Keywords

remimazolam; cataract surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Subjects' scores using the Aldrete Postanesthetic Recovery assessment

  During the time subject is in the post anesthesia care unit (PACU)

• Subjects' scores on the Richmond Agitation Sedation Scale (RASS)

  During the time subject is in the post anesthesia care unit (PACU)

• Subjects' scores on patient satisfaction questionnaires

  Questionnaire will be completed the day after surgery

Other Outcomes (1)

• Patients' Indirect costs

  1 year

Study Arms (2)

Arm 1 Cataract Surgery performed with remimazolam as sedative

EXPERIMENTAL

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

Arm 2 Cataract Surgery performed with a standard of care sedative

PLACEBO COMPARATOR

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

Interventions

Arm 2 Cataract Surgery performed with standard of care sedative DRUG

Standard of care sedative will be used during surgery.

Arm 2 Cataract Surgery performed with a standard of care sedative

Arm 1 Cataract Surgery performed with remimazolam as sedative DRUG

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

Arm 1 Cataract Surgery performed with remimazolam as sedative

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred E, Shapiro: lead
• Eagle Pharmaceuticals, Inc.: collaborator
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 40704218 BACKGROUND

MeSH Terms

Interventions

remimazolam; Hypnotics and Sedatives

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Vikranth R. Chinthareddy, BA

CONTACT

617-573-3380; vchinthareddy@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be scheduled for cataract surgery in both eyes and they will serve as their own control, having sedation with the study drug remimazolam in one cataract surgery, and the standard of care sedation drug in the second surgery. To control for "second eye syndrome" a phenomenon where patients report increased discomfort, sensitivity, and / or slower healing at their second cataract surgery compared to the first, (even if no preoperative or intraoperative factor for that opinion could be identified) half of the subjects will have remimazolam as a sedative in their first cataract surgery and half will have it at the second surgery. Subjects will be blinded as to which sedation drug is used in each surgery.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 8, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• 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.
• Access Criteria: The consent form will be available to members of the public that read this record on Clinicaltrials.gov.

Locations

US (1)