Skip to main content
OpenTrials
Completed

NCT Number: NCT06506669

Cataract Monitored Anesthesia Care (MAC) 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Anesthesia Behavior Bilateral Senile Cataract Eye Diseases Health Behavior Lens Diseases Patient Satisfaction Treatment Adherence and Compliance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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

Treatment and study plan

Oral sedation

Procedure

Oral medication for anxiolysis administered in the preoperative setting

Placebo

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CaTNAPS-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.