Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | self-rehabilitation at home. Intervention 25 min/day, 5 days a week for 6 weeks at home (weekly load of 125 minutes), on a dichoptic reading application on a loaned digital tablet, wearing anaglyph glasses provided and patient's optical correction (if applicable). |
|
| Control group | Active Comparator | The control group will receive conventional treatment consisting of 12 sessions of 25 minutes each over 6 weeks of rehabilitation with an orthoptist in the ophthalmology department of Montpellier University Hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-education with dichoptic reading on tablet | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Céline Mrs. LORENZINI, Dr | Contact | 04 67 33 50 17 | marie-celine.lorenzini@chu-montpellier.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, single-center, randomized, controlled, non-inferiority, open-label study with blinded assessment of primary endpoint.
Not provided
Not provided
An orthoptist fwho may also be in charge of rehabilitation, will carry out the initial assessment (near convergence amplitude, punctum proximum of convergence,...).
Another orthoptist will perform the same assessments at S3 and S6, blinded to the treatment arms and initial measurements to avoid bias:
Another orthoptist in the department, different from the blinded orthoptist, will provide conventional rehabilitation and will not be blinded to the treatment groups assigned to his or her patients. This orthoptist designated for rehabilitation may also be in charge of the initial evaluation.
The department's CRA will be vigilant from the outset to define who will be the blinded orthoptist assessor (assessments at S3 and S6) and the orthoptist rehabilitator and/or assessor for the initial visit. Randomization will be carried out by a CRA, who will only reveal the randomization arm to the orthoptist designated for rehabilitation and/or initial assessment.
|
| Conventional orthoptic rehabilitation | Procedure | 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). |
|
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 :
Partial response:
| 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 |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
Not provided
Not provided