Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study (CaTNAPS-1)

June 11, 2026 updated by: University of California, San Francisco

Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 assess the feasibility, completeness, and distribution of data in measuring 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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Oral sedation will be administered to patients prior to the procedure.
Procedure: Oral sedation
Oral medication for anxiolysis administered in the preoperative setting
Placebo Comparator: Placebo
An oral placebo pill will be administered to patients prior to the procedure.
Procedure: Placebo
A placebo pill with no active ingredients administered in the preoperative setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With High Satisfaction (ISAS Score ≥ 2)
Time Frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction.

For this analysis, high satisfaction is defined as an ISAS score ≥ 2.
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Meeting Eligibility Criteria at Screening
Time Frame: At screening (prior to enrollment)
Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility
At screening (prior to enrollment)
Number of Participants Completing All Study Surveys at Each Timepoint
Time Frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Number of Participants Who Completed All Required Study Procedures
Time Frame: From enrollment through final study follow-up (POD7)

Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study

Instruments:

Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI)
From enrollment through final study follow-up (POD7)
Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
Time Frame: From enrollment through 30 days after surgery
Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study
From enrollment through 30 days after surgery
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
Time Frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains.

For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point.
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Quality of Recovery-15 (QoR-15) Total Score After Surgery
Time Frame: 1 day and 7 days after surgery
The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence. Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150. Higher scores indicate better recovery.
1 day and 7 days after surgery
Functional Recovery Index (FRI) Total Score After Surgery
Time Frame: 1 day and 7 days after surgery
The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living. Each item is scored and summed to produce a total score ranging from 0 to 100. Lower scores indicate better functional recovery.
1 day and 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Catherine L Chen, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Actual)

May 6, 2025

Study Completion (Actual)

May 29, 2025

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-40367
  • 5K23AG072035-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small single center pilot study so we do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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