Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529016
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Using Dichoptic Therapy to Treat Intermittent Exotropia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Dichoptic Therapy to Treat Intermittent Exotropia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Intermittent exotropia is difficult to treat The mainstay of treatment involves surgery and in one long-term study authors found that as many as 60 of IXT required at least one re-operationPatching of the non-dominant eye has also been tested in a large multi-center randomized control trial and was not found to have a large benefit More non-surgical treatment modalities are critical to improve the care in this condition
Detailed Description:
Luminopia a dichoptic therapy device was approved by the FDA in 2021 for use in amblyopia in children aged 4-7 years The device was shown to improve vision in the amblyopic eye by lines in three months of use Patients with strabismic amblyopia were also enrolled in the trial and found to have similar gains in vision in the amblyopic eye
Li et al used an investigational dichoptic therapy device in patients with intermittent exotropia and had a statistically significant improvement in ocular alignment as measured in prism dioptersThe dichoptic therapy this study used is not commercially available therefore using Luminopia to study this population may result in an immediately available non-surgical treatment for intermittent exotropia patients
Li et al used an investigational dichoptic therapy device in patients with intermittent exotropia and had a statistically significant improvement in ocular alignment as measured in prism dioptersThe dichoptic therapy this study used is not commercially available therefore using Luminopia to study this population may result in an immediately available non-surgical treatment for intermittent exotropia patients
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