Effect of Binocular Treatment Using a Dichoptic Reading Application in Children With Convergence Insufficiency.
NCT Number: NCT06465615
Acronym: ALEDICE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ophthalmological Disorder
Interventions: DEVICE: Self-education with dichoptic reading on tablet|PROCEDURE: Conventional orthoptic rehabilitation
Sponsor: University Hospital, Montpellier
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: CHILD
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01

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.

Primary Outcome Measures: Evolution of symptoms at the end of the intervention, Evolution of symptoms assessed via the Convergence Insufficiency Symptom Survey (CISS) score, version 15, measured before and 6 weeks after the start of the intervention in children with convergence insufficiency., T0 and T6 weeks|Evolution of symptoms halfway through the intervention, Evolution of symptoms (decrease in Convergence Insufficiency Symptom Survey (CISS) score measured 3 weeks after the start of binocular treatment), T0 and T3 weeks
Secondary Outcome Measures: Evolution of the punctum proximum of convergence (PPC), This test defines the closest point of fixation to the patient on which the 2 eyes can converge and see simply. It is measured using the Astron ACR/21 international accommodative rule., T0 and T3 weeks and T0 and T6 weeks|Evolution of stereoacuity, The McGill clinical stereo test (McGill University) evaluates relief vision (threshold expressed in arcseconds) through a digital tablet with red-green anaglyph glasses., T0 and T3 weeks and T0 and T6 weeks|Normalization of fusion amplitude in near convergence, A fusion amplitude in near-normal convergence is defined as greater than 15Δ and satisfying Sheard's criterion., T0 and T3 weeks ans T0 and T6 weeks|Normalization of punctum proximum of convergence (PPC), A normal convergence punctum proximum is defined as less than 6 cm., T0 and T3 weeks ans T0 and T6 weeks|Evolution of reading speed, reading speed assessed by the Minnesota Low Vision Reading Test (MNREAD) in seconds., T0 and T3 weeks ans T0 and T6 weeks|Interocular suppression measured with the Dichoptic Contrast Ordering Test (DICOT), Interocular suppression measured with the Dichoptic Contrast Ordering Test (DICOT), T0 and T3 weeks ans T0 and T6 weeks|Changes in quality of life, Quality of life measured with the Pediatric Quality of Life Inventory (PedsQL), T0 and T3 weeks ans T0 and T6 weeks|Prevalence of patients with "Complete Response", "Partial Response" and "Nonresponders, Prevalence of patients with "Complete Response", "Partial Response" and "Nonresponders", defined as follows:

Complete response :

* ISSC score \<16
* AND normal convergence punctum proximum (i.e. less than 6 cm)
* AND normal near convergence fusion amplitude (i.e. greater than 15Δ and satisfying Sheard's criterion).

Partial response:

* CISS score \<16 or 10-point decrease in CISS
* AND :

  * Normal convergence punctum proximum
  * OR improvement in convergence proximal punctum of more than 4 cm
  * OR normal near convergence fusion amplitude
  * OR increase in near convergence fusion amplitude by more than 10Δ. Non-responders: Patients not meeting the criteria for success or improvement., T3 weeks and T6 weeks|Treatment compliance, For the experimental group, compliance is measured using a percentage of training sessions completed, obtained from automatic recording by the tablet software and the patient diary, in which the date and duration (seconds) of each training session are recorded. For the control group, compliance is measured using a percentage combining the number of training sessions performed (collected by the orthoptist) and home exercises (self-reported by the patient), with dates and durations recorded in a patient logbook., T3 weeks and T6 weeks|Adherence to self-training, Adherence to self-training evaluated in a patient logbook: training time completed vs. training time planned., T3 weeks and T6 weeks|Visual comfort when using the dichoptic reading application, Measurement of visual comfort when using the dichoptic reading application with the modified Convergence Insufficiency Symptom Survey score.The modified Convergence Insufficiency Symptom Survey score ranges from 0 to 60. Higher scores mean a worse outcome, indicating a high presence of symptoms., T3 weeks and T6 weeks|Level of certainty of recognition of the patient randomization arm for the evaluating orthoptist, Likert scale assessing the evaluator's level of certainty regarding recognition of the patient's allocation to the experimental arm. The modified Convergence Insufficiency Symptom Survey score ranges from 0 to 4. higher scores mean a better outcome, indicating a low level of certainty of recognition of patient randomization arm., T3 weeks and T6 weeks|Adverse events, Collection of adverse events self-reported by the patient and collected by the medical team during assessment visits., T3 weeks ands T6 weeks