Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029530
Status:
WITHDRAWN
Last Update Posted:
2024-04-16
First Post:
2023-08-24
Brief Title:
Delaying the Onset of Nearsightedness Until Treatment Study
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Delaying the Onset of Nearsightedness Until Treatment Study
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DONUT
Brief Summary:
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month
Detailed Description:
Participants will be identified through screening that fit the criteria of a pre-myopic child which will depend on age and the amount of refractive error at that time These children will be randomized for a pilot study measuring compliance in nightly eye drop administration The outcome will be thirty days after randomization and will assess whether or not there is a difference in compliance between one of three dosages of atropine 001 003 and 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None