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

August 14, 2025 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 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.

Study Overview

Status

Active, not recruiting

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 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.

Study Type

Interventional

Enrollment (Estimated)

20

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
Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)
Time Frame: 30 minutes, 1 day and 7 days after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients meeting eligibility criteria
Time Frame: Through study completion, an average of 1 year
Number of patients meeting eligibility criteria divided by the total number of patients screened
Through study completion, an average of 1 year
Proportion of patients completing all study surveys after cataract surgery
Time Frame: Through study completion, an average of 1 year
Number of patients completing all study surveys after cataract surgery divided by the number of patients enrolled in the study
Through study completion, an average of 1 year
Proportion of study patients who completed all required study procedures
Time Frame: Through study completion, an average of 1 year
The number of study patients who completed all required study procedures (before and after surgery) divided by the number of patients enrolled in the study.
Through study completion, an average of 1 year
Incidence of sedation-related complications after surgery
Time Frame: 30 days after surgery
The number of patients with a sedation-related complication divided by the number of patients enrolled in the study.
30 days after surgery
Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS)
Time Frame: 30 minutes, 1 day and 7 days after surgery
The PQRS is a 6-question survey that assesses the quality of recovery of patients after surgery. It evaluates multiple aspects of recovery, including physiological, pain, emotional, brain function, and activities of daily living domains.
30 minutes, 1 day and 7 days after surgery
Quality of recovery after surgery as measured by the Quality-of-Recovery-15 Questionnaire (QoR-15)
Time Frame: 1 day and 7 days after surgery
The QoR-15 is a survey that has 15 questions and is used to see how patients feel after surgery and helps to understand the trajectory of recovery from surgery and anesthesia. The survey includes questions about mood, including if patients are feeling anxious or depressed.
1 day and 7 days after surgery
Quality of recovery after surgery as measured by the Functional Recovery index (FRI)
Time Frame: 1 day and 7 days after surgery
The FRI is a 14-question survey to check how well patients can do normal activities after surgery. It asks about things like pain, moving around, and daily activities.
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 (Estimated)

August 1, 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)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

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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