Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

NCT ID: NCT06506669

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-08-31

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.

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 an oral placebo pill (control). The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.

Conditions

Cataract; Bilateral Senile Cataract; Anesthesia; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Oral sedation

Intervention Type: PROCEDURE

Oral medication for anxiolysis administered in the preoperative setting

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

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

Interventions

Oral sedation

Oral medication for anxiolysis administered in the preoperative setting

Intervention Type: PROCEDURE

Placebo

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. ≥ 60 years old

2. Capable of providing informed consent and completing the study procedures in English

3. Able to provide consent for oneself

4. Able to follow directions

5. Able to climb one flight of stairs without stopping to rest

6. Have a new diagnosis of cataract disease

7. Plan on having cataract surgery on their eye within the next 6 months

Exclusion Criteria

1. History of prior cataract surgery

2. Admission to the hospital within the past 30 days

3. Difficulty being sedated during other minor outpatient procedures or imaging studies

4. Allergy or resistance to local anesthetic agents

5. Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)

6. History of severe anxiety requiring routine use of benzodiazepines

7. Severe valve disease (e.g., critical aortic stenosis)

8. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)

9. Untreated chest pain or angina

10. Patients with movement disorders (e.g., Parkinson's Disease)

11. History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures

12. Require home oxygen (O2) at rest or with exertion

13. End-stage renal disease (ESRD) requiring dialysis

14. Morbid obesity (BMI>35)

15. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure

16. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine L Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

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Other Identifiers

5K23AG072035-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-40367

Identifier Type: -

Identifier Source: org_study_id