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

NCT06465615 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Ophthalmological Disorder

Interventions

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).

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-05-01
Completion
2025-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465615 on ClinicalTrials.gov