Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study (NCT06506669) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
United States20 participantsStarted 2024-06-12
Plain-language summary
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.
Who can participate
Age range
60 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
. ≥ 60 years old
. Capable of providing informed consent and completing the study procedures in English
. Able to provide consent for oneself
. Able to follow directions
. Able to climb one flight of stairs without stopping to rest
. Have a new diagnosis of cataract disease
. Plan on having cataract surgery on their eye within the next 6 months
Exclusion criteria
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
Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)
Timeframe: 30 minutes, 1 day and 7 days after surgery
. Admission to the hospital within the past 30 days
. Difficulty being sedated during other minor outpatient procedures or imaging studies
. Allergy or resistance to local anesthetic agents
. Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
. History of severe anxiety requiring routine use of benzodiazepines
. Severe valve disease (e.g., critical aortic stenosis)
. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)