Ophthalmological Disorder Clinical Trial
Official title:
Effect of Binocular Dichoptic Reading Treatment on Visual Function in Children With Symptomatic Convergence Insufficiency: a Pilot Noninferiority Study. ALEDICE
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.
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. ;
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