Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01087489
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2010-03-15
Brief Title:
Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye
Sponsor:
Miami VA Healthcare System
Organization:
Miami VA Healthcare System
Study Overview
Official Title:
Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
Status:
COMPLETED
Status Verified Date:
2012-11
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:
None
Brief Summary:
Patient comfort during and after eye injections will be compared after two numbing anesthetic protocols an eye preparation utilizing three cotton swabs soaked in 4 lidocaine drops versus a preparation using 35 lidocaine hydrochloride ophthalmic gel
Detailed Description:
The primary goal of this investigation is to determine the relative comfort of an intravitreal injection same day and the next day after a preparation utilizing three cotton swabs soaked in 4 lidocaine versus a preparation using 35 lidocaine hydrochloride ophthalmic gel Based on the available data the researchers contend that a preparation based on viscous 35 ophthalmic lidocaine gel which coats the surface and remains in contact with the eye longer may provide greater anesthesia and result in greater patient comfort than the topical 4 lidocaine which is part of the standard preparation routinely utilized in the ophthalmology department currently Secondary outcome measure is the intraocular pressure rise after the injection and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike
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