RECRUITING

Oral vs IV Sedation for Cataract Surgery in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.

Official Title

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

Quick Facts

Study Start:2025-08-12
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07154147

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.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 65 years old
  2. 2. Capable of providing informed consent and completing the study procedures in English
  3. 3. Able to provide consent for oneself
  4. 4. Able to follow directions
  5. 5. Able to climb one flight of stairs without stopping to rest
  6. 6. Have a new diagnosis of cataract disease
  7. 7. Plan on having cataract surgery on their eye within the next 6 months
  1. 1. History of prior cataract surgery
  2. 2. Admission to the hospital within the past 30 days
  3. 3. Difficulty being sedated during other minor outpatient procedures or imaging studies
  4. 4. Allergy or resistance to local anesthetic agents
  5. 5. Cannot lay flat without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
  6. 6. History of severe anxiety requiring routine use of benzodiazepines
  7. 7. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
  8. 8. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure

Contacts and Locations

Study Contact

Jacob A Flores, MPH
CONTACT
5598539089
jacob.flores@ucsf.edu
Catherine L Chen, MD, MPH
CONTACT
4108688440
catherine.chen@ucsf.edu

Principal Investigator

Catherine L Chen, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay
San Francisco, California, 94117
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Catherine L Chen, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Registration Dates

Study Start Date2025-08-12
Study Completion Date2025-11

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • oral sedation
  • intravenous sedation
  • alprazolam
  • midazolam
  • cataract surgery
  • older adults
  • cognitive recovery
  • postoperative recovery
  • patient satisfaction
  • non-inferiority trial
  • pilot study
  • randomized controlled trial
  • anesthesia

Additional Relevant MeSH Terms

  • Cataract Surgery
  • Sedation
  • Cognition Function
  • Perioperative Care
  • Older Adults