Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465615
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Effect of Binocular Treatment Using a Dichoptic Reading Application in Children With Convergence Insufficiency
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Effect of Binocular Dichoptic Reading Treatment on Visual Function in Children With Symptomatic Convergence Insufficiency a Pilot Noninferiority Study ALEDICE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ALEDICE
Brief Summary:
Convergence insufficiency is a common disorder of binocular vision that can appear as early as childhood after visual effort and is often associated with a variety of symptoms such as eyestrain headaches blurred vision and diplopia
Treatment of symptomatic convergence insufficiency generally involves the intentional and controlled manipulation of a visual targets blur conjugate and vergence movements around this target with the aim of normalizing the accommodation and vergence systems and their mutual interactions
Despite the effectiveness of this treatment compliance is not optimal ranging from 24 to 91 in the youngest patients One of the main challenges is to keep patients focused and interested during the potentially tedious and repetitive periods of over-convergence In order to stimulate the patients active participation and stable sustained attention a dichoptic reading application on a digital tablet has been developed to provide sustained training in ocular alignment and coordination to reduce symptoms and restore binocular function in patients with symptomatic convergence insufficiency
Treatment of symptomatic convergence insufficiency generally involves the intentional and controlled manipulation of a visual targets blur conjugate and vergence movements around this target with the aim of normalizing the accommodation and vergence systems and their mutual interactions
Despite the effectiveness of this treatment compliance is not optimal ranging from 24 to 91 in the youngest patients One of the main challenges is to keep patients focused and interested during the potentially tedious and repetitive periods of over-convergence In order to stimulate the patients active participation and stable sustained attention a dichoptic reading application on a digital tablet has been developed to provide sustained training in ocular alignment and coordination to reduce symptoms and restore binocular function in patients with symptomatic convergence insufficiency
Detailed Description:
The dichoptic reading application on a digital tablet consists in reading with red-green anaglyph glasses a text composed of letters or words presented both binocularly and monocularly black and red-green respectively from downloaded e-books After centralized randomization patients will undergo either reference orthoptic rehabilitation control group or dichoptic treatment on a digital tablet experimental group The control group will receive 12 training sessions 25 minutes twice a week for 6 weeks as part of their regular treatment in the Ophthalmology Department of the CHU de Montpellier while the experimental group will perform self-training at home 25 minday 5 days a week for 6 weeks For all participants an initial visit and two follow-up evaluation visits visits 2 and 3 will be scheduled 3 and 6 weeks 1 week after the start of the intervention and will be carried out by one of the 3 other orthoptists in the Ophthalmology Department of the CHU de Montpellier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None