Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-02 @ 9:01 AM
Study NCT ID:
NCT06506669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaTNAPS-1
Brief Summary:
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol 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.
Detailed Description:
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 compare differences in 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5K23AG072035-03 | NIH | None | https://reporter.nih.gov/quic… | View |