Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

Completed · Not applicable · Has a placebo group

Conditions studied: Cataract, Bilateral Senile Cataract, Anesthesia, Patient Satisfaction

In brief

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes 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.

Key facts

Study ID

NCT06506669

Run by

University of California, San Francisco

People needed

23

Starts

2024-06-12

Expected to finish

2025-05-29

Last updated by the study team

2026-07-09

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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