Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506669
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Cataract Monitored Anesthesia Care MAC Feasibility Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery A Prospective Feasibility Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 n10 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None