Study of Remimazolam for Cataract Surgery (NCT07325227) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Study of Remimazolam for Cataract Surgery
United States30 participantsStarted 2026-04-28
Plain-language 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.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of sedation-related adverse events
Timeframe: 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
2
The severity of sedation-related adverse events
Timeframe: 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
The duration of sedation-related adverse events
Timeframe: 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
4
Time that subject remains in the post anesthesia care unit (PACU)
Timeframe: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge