Status:
ACTIVE_NOT_RECRUITING
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Conditions:
Cataract
Bilateral Senile Cataract
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 e...
Detailed Description
This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or ...
Eligibility Criteria
Inclusion
- ≥ 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
- 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)
- Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
- Untreated chest pain or angina
- Patients with movement disorders (e.g., Parkinson's Disease)
- History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
- Require home oxygen (O2) at rest or with exertion
- End-stage renal disease (ESRD) requiring dialysis
- Morbid obesity (BMI\>35)
- Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
- Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure
Key Trial Info
Start Date :
June 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06506669
Start Date
June 12 2024
End Date
August 1 2025
Last Update
August 17 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143