RECRUITING

Oral vs IV Sedation for Cataract Surgery in Older Adults

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.

Conditions

Cataract SurgerySedationCognition FunctionPerioperative CareOlder Adults
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Related Conditions:

Cataract SurgerySedationCognition FunctionPerioperative CareOlder Adults

Study Overview

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Study Details

Study overview

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.

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

Oral vs IV Sedation for Cataract Surgery in Older Adults

Condition
Cataract Surgery
Intervention / Treatment

-

Contacts and Locations

San Francisco

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ≥ 65 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
  • 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 without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
  • 6. History of severe anxiety requiring routine use of benzodiazepines
  • 7. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
  • 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

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

Study Record Dates

2025-11