Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02594358
Status:
WITHDRAWN
Last Update Posted:
2017-03-07
First Post:
2015-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine in Amblyopia Study
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Could not recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAS
Brief Summary:
Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).
Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.
Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.
Demonstrate recruitment potential of subjects to participate in a dietary intervention study.
Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.
Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.
Demonstrate recruitment potential of subjects to participate in a dietary intervention study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: