NCT06465615

Effect of Binocular Treatment Using a Dichoptic Reading Application in Children With Convergence Insufficiency.

Effect of Binocular Dichoptic Reading Treatment on Visual Function in Children With Symptomatic Convergence Insufficiency: a Pilot Noninferiority Study. ALEDICE

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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 target's 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 patient's 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 min/day, 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.

Conditions

• Ophthalmological Disorder

Interventions

Type	Name	Description
DEVICE	Self-education with dichoptic reading on tablet	Intervention 25 min/day, 5 days a week for 6 weeks at home (125-minute weekly load), under the supervision of a parent, on a dichoptic reading application on a loaned digital tablet, wearing anaglyph glasses provided and the patient's optical correction (if applicable). During the first half of treatment (first 3 weeks), dichoptic separation takes place at the word level, and during the second half of treatment (last 3 weeks), it takes place at the individual letter level to promote precise eye alignment. This shift from dichoptic separation at word level to letter level increases the difficulty of the task. The text is freely chosen by the child and parent from a bank of age-appropriate books.
PROCEDURE	Conventional orthoptic rehabilitation	Conventional orthoptic rehabilitation consisting of 12 x 25-minute sessions twice a week over 6 weeks, carried out with an orthoptist from Montpellier University Hospital, combined with reinforcement exercises to be carried out at home for 15 minutes a day under parental supervision, 5 days a week (125-minute weekly load). This is the standard orthoptic treatment offered in France to patients with symptomatic convergence insufficiency, according to orthoptic procedures (10-15 sessions of the order of 20-25 minutes and 10-15 minutes of daily reinforcement exercises at home).

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2024-06-20
• Last updated: 2024-07-23