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 range60 Years
SexALL
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
✕. History of prior cataract 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)
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
. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)