Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

NCT06506669 | Active Not Recruiting

• 2 other identifiers: 23-403675K23AG072035-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cataract; Bilateral Senile Cataract; Anesthesia; Patient Satisfaction

Keywords

cataract surgery; oral sedation; intravenous sedation; conscious sedation; monitored anesthesia care; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)

  The ISAS is a validated 11-question survey to find out how people feel about the sedation (i.e., monitored anesthesia care) they received during surgery that doesn't require general anesthesia. It asks about pain and overall feelings about the anesthesia care received. We will compare ISAS scores between patients who received oral sedation and patients who received placebo.

  30 minutes, 1 day and 7 days after surgery

Secondary Outcomes (7)

• Proportion of patients meeting eligibility criteria

  Through study completion, an average of 1 year

• Proportion of patients completing all study surveys after cataract surgery

  Through study completion, an average of 1 year

• Proportion of study patients who completed all required study procedures

  Through study completion, an average of 1 year

• Incidence of sedation-related complications after surgery

  30 days after surgery

• Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS)

  30 minutes, 1 day and 7 days after surgery

Study Arms (2)

Intervention

EXPERIMENTAL

Oral sedation will be administered to patients prior to the procedure.

Procedure: Oral sedation

Placebo

PLACEBO COMPARATOR

An oral placebo pill will be administered to patients prior to the procedure.

Procedure: Placebo

Interventions

Oral sedation PROCEDURE

Oral medication for anxiolysis administered in the preoperative setting

Intervention

Placebo PROCEDURE

A placebo pill with no active ingredients administered in the preoperative setting

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (51)

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MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Catherine L Chen, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, clinicians (operating room nurses, ophthalmologists, and anesthesia staff), and research staff responsible for data collection and analysis will be blinded to the treatment group in order to minimize bias and maximize the validity of results.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, double-blinded, randomized pilot clinical trial

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 17, 2024
• Study Start: June 12, 2024
• Primary Completion: May 6, 2025
• Study Completion: August 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)