Exploring Sedation Types During Cataract Surgery (NCT04725747) | Clinical Trial Compass
CompletedNot Applicable
Exploring Sedation Types During Cataract Surgery
United States1,111 participantsStarted 2021-01-25
Plain-language summary
This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to IV sedation in subjects undergoing intraocular surgery.
Who can participate
Age range
55 Years – 80 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
. Subjects must be male or female, and between the ages of 55-80 years old.
. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
. Subjects that are willing to have an IV placed prior to intraocular surgery
. Subjects undergoing first eye cataract surgery
. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.
Exclusion criteria
. Subjects who have undergone sedation in the past 90 days.
. Women who are pregnant or lactating at the time of the study.
. Subjects who do not wish to or cannot comply with study procedures.
. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
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.
. Subjects that are currently taking a prescription pain medication.
. Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.