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Study of Remimazolam for Cataract Surgery

This study is looking at whether a sedative called remimazolam (Byfavo) can make cataract surgery safer for patients. Researchers want to see if remimazolam reduces problems related to sedation during and after surgery, and helps people recover their thinking skills faster. You might be able to join if you are between 55 and 90 years old, need cataract surgery in both eyes, and your surgeries are expected to take less than 30 minutes each. The study is currently unclear on its recruitment status. Success for this study would mean fewer and less severe sedation-related side effects, and a quicker return to normal cognitive function after surgery.

Study design
This interventional study plans to enroll 30 participants. For each participant, one eye will receive remimazolam as a sedative, and the other eye will receive the standard sedative.
What's involved
You will consent to participate on the day of surgery. Adverse event data will be collected during surgery, through the following day, and up to one week after surgery.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be documented up to one week after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07325227

Study of Remimazolam for Cataract Surgery

Not Yet Recruiting
PHASE4Ages 55–90InterventionalPrevention
Fred E, Shapiro
~30 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Arm 1 Cataract Surgery performed with remimazolam as sedativeArm 2 Cataract Surgery performed with standard of care sedative

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of sedation-related adverse events
Measured over 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
+3 more outcomes measured

Conditions

Cataract Surgery Anesthesia

Explore related trials

Cataract

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Vikranth R. Chinthareddy, BA
[email protected]
617-573-3380
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The number of sedation-related adverse eventsSubjects 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 number of sedation-related adverse events from the time sedation is administered at the start of surgery through up to one week post-surgery.

  • The severity of sedation-related adverse eventsSubjects 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 (mild, moderate or severe) of sedation-related adverse events

  • The duration of sedation-related adverse eventsSubjects 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, in minutes, hours, or days of sedation-related adverse events

  • Time that subject remains in the post anesthesia care unit (PACU)Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge

    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.