Oral vs IV Sedation for Cataract Surgery in Older Adults
Completed · Phase 4 · Has a placebo group
Conditions studied: Cataract Surgery, Sedation, Cognition Function, Perioperative Care, Older Adults
In brief
The goal of this clinical trial is to evaluate the feasibility of comparing oral sedation (a pill) with intravenous (IV) sedation for cataract surgery in older adults. Investigators will assess the feasibility, completeness, and distribution of data related to postoperative recovery, including thinking and memory, as well as participant satisfaction with care. Participants will be randomly assigned to receive either oral sedation with an IV placebo or IV sedation with an oral placebo before cataract surgery. Participants will complete brief surveys assessing recovery before and after surgery and will be contacted by phone after surgery to assess postoperative recovery. Results from this pilot study will inform the design of a future, fully powered trial evaluating sedation approaches for cataract surgery.
Key facts
- Study ID
- NCT07154147
- Run by
- University of California, San Francisco
- People needed
- 20
- Starts
- 2025-08-12
- Expected to finish
- 2026-01-19
- Last updated by the study team
- 2026-04-27
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 65 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
You may not qualify if…
- 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 without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
- History of severe anxiety requiring routine use of benzodiazepines
- 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
Where it is running
- UCSF Wayne and Gladys Valley Center for Vision, Mission Bay — San Francisco, California, United States
Full record on ClinicalTrials.gov
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