Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380517
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ATS23
Brief Summary:
In children 4 to 7 years of age to determine if treatment with 1 hour per day 6 days per week of watching dichoptic moviesshows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks
Detailed Description:
Participants eligible for the study will be randomly allocated 11 to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13 and 26-weeks post-randomization
At the 26-week primary outcome visit participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more will be offered Luminopia dichoptic therapy and if they accept followed forward with visits at 39- and 52-weeks post-randomization
The study will end for all other participants
At the 26-week primary outcome visit participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more will be offered Luminopia dichoptic therapy and if they accept followed forward with visits at 39- and 52-weeks post-randomization
The study will end for all other participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2UG1EY011751 | NIH | None | httpsreporternihgovquickSearch2UG1EY011751 |