Oral vs IV Sedation for Cataract Surgery in Older Adults (NCT07154147) | Clinical Trial Compass
CompletedPhase 4
Oral vs IV Sedation for Cataract Surgery in Older Adults
United States20 participantsStarted 2025-08-12
Plain-language summary
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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. ≥ 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
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
What they're measuring
1
Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS)
Timeframe: Before surgery; immediately after surgery; post-operative day 1; post-operative day 7
✕. 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