Remimazolam for Cataract Surgery

Overseen By Vikranth R. Chinthareddy, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Fred E, Shapiro

Must not be taking: Narcotics, Anxiolytics

Disqualifiers: Cognitive decline, Severe hepatic impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using the sedative remimazolam during cataract surgery can enhance safety by reducing sedation-related issues and speeding up mental recovery post-surgery. Participants will undergo cataract surgery in both eyes, with remimazolam used for one eye and the standard sedative for the other, without knowing which is used when. Ideal candidates are those planning cataract surgery in both eyes, with each procedure expected to last under 30 minutes, and who have not experienced sedation problems before. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial requires that you do not use home narcotic or anxiolytic medications (drugs that relieve anxiety) while participating. If you are currently using these, you may need to stop.

What is the safety track record for remimazolam?

Research has shown that remimazolam is generally safe as a sedative. Studies have found it has a good safety record, causing only minor side effects. In one previous study, remimazolam helped patients relax during procedures and was well-received. Notably, there were very few reports of serious adverse reactions. This suggests that remimazolam could be a safe choice for patients undergoing cataract surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Remimazolam is unique because it offers a potentially faster onset and shorter duration of sedation compared to standard sedatives like midazolam for cataract surgery. Researchers are excited about this treatment because its rapid clearance from the body could lead to quicker recovery times and fewer side effects, making the procedure more comfortable and efficient for patients. Unlike other treatments that may linger in the system, remimazolam’s properties allow for precise control over sedation, which is particularly beneficial in outpatient settings like cataract surgery.

What is the effectiveness track record for remimazolam in cataract surgery?

This trial will compare remimazolam as a sedative to the standard sedative used for cataract surgery. Studies have shown that remimazolam effectively calms patients with minimal side effects. It helps patients regain their thinking and memory abilities faster after surgery, making it a suitable option for cataract procedures where quick recovery is crucial. Previous patients experienced good sedation and faster recovery times with remimazolam compared to some other sedatives. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients who need cataract surgery and are suitable for sedation. Specific eligibility criteria aren't provided, but typically participants must be in good health with no conditions that could interfere with the study or increase risk.

Inclusion Criteria

I am planning to have cataract surgery on both eyes.

My cataract surgery is expected to last under 30 minutes.

I am between 55 and 90 years old.

Exclusion Criteria

Subject does not speak or read English

Subject has a history of difficulty with sedation during procedures

My surgeon expects my cataract surgery to last over 30 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo cataract surgery with either remimazolam or standard of care sedation

1 day

1 visit (in-person)

Immediate Post-Surgery Monitoring

Participants are monitored in the post anesthesia care unit (PACU) until they meet discharge criteria

Less than 60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for sedation-related adverse events and complete satisfaction questionnaires

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Remimazolam

Trial Overview

The study compares two groups: one receiving remimazolam as a sedative during cataract surgery, and another receiving the standard sedative. The aim is to see if remimazolam can reduce complications and aid faster cognitive recovery post-surgery.

How Is the Trial Designed?

Group I: Arm 1 Cataract Surgery performed with remimazolam as sedative Experimental Treatment 1 Intervention

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 II: Arm 2 Cataract Surgery performed with a standard of care sedative Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Fred E, Shapiro

Lead Sponsor

Eagle Pharmaceuticals, Inc.

Industry Sponsor

Trials

7

Recruited

1,000+

Massachusetts Eye and Ear Infirmary

Collaborator

Trials

115

Recruited

15,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07325227

NCT07325227 | Study of Remimazolam for Cataract Surgery

The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12416394/

Determination of the 90% Effective Dose of Remimazolam ...

Data Collection and Outcome Assessment. The primary outcome was the effective or ineffective dose of remimazolam for preventing ED. Secondary ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05980117?term=Cataract%2018&viewType=Table&rank=7

NCT05980117 | Remimazolam for Cataract Surgery

The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery.

4.

uclahealth.org

uclahealth.org/clinical-trials/remimazolam-cataract-surgery

Remimazolam for Cataract Surgery

The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery.

5.

withpower.com

withpower.com/trial/phase-4-cataract-surgery-anesthesia-1-2026-27448

Remimazolam for Cataract Surgery · Info for Participants

The study compares two groups: one receiving remimazolam as a sedative during cataract surgery, and another receiving the standard sedative. The aim is to see ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12793993/

Remimazolam: a comprehensive review - PMC

A phase III study demonstrated that remimazolam provides effective procedural sedation with a favorable safety profile, characterized by minimal ...