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

NCT06465615 | Not Yet Recruiting

• 1 other identifier: RECHMPL22_0552
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Convergence insufficiency; therapy, Vision, Binocular; physiology, Vision, Monocular; physiology, Depth Perception; physiology, Contrast Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Evolution of the punctum proximum of convergence (PPC)

  T0 and T3 weeks and T0 and T6 weeks

• Evolution of stereoacuity

  T0 and T3 weeks and T0 and T6 weeks

• Normalization of fusion amplitude in near convergence

  T0 and T3 weeks ans T0 and T6 weeks

• Normalization of punctum proximum of convergence (PPC)

  T0 and T3 weeks ans T0 and T6 weeks

• Evolution of reading speed

  T0 and T3 weeks ans T0 and T6 weeks

Study Arms (2)

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).

Device: Self-education with dichoptic reading on tablet

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.

Procedure: Conventional orthoptic rehabilitation

Interventions

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.

Experimental group

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).

Control group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 8 to 17
• Minimum current schooling: CE2 class
• Availability of at least one legal guardian to supervise the child's training (strengthening exercises to be performed at home 15 min/day for the control group/ 25 min/day session at home for the experimental group) and complete the patient logbook.
• Convergence Insufficiency Symptom Survey (CISS) score ≥ 16
• Convergence punctum proximum ≥ 6 cm
• Amplitude of fusion in near convergence ≤ 15 prismatic dioptres or less than 2 times the phoria measured in near vision (Sheard's criterion).
• See letters/words and be able to read 3 complete sentences on a predefined text presented dichoptically on the tablet with anaglyph glasses
• Availability of the patient to complete the training protocol over 6 weeks (or a maximum of 9 weeks in the event of temporary interruption of treatment).

You may not qualify if:

• Binocular vergence dysfunctions such as constant strabismus
• History of recent orthoptic rehabilitation (\< 6 months)
• History of intraocular or refractive surgery
• Current amblyopia treatment or treated amblyopia (isoacuity) \< 6 months
• Best corrected visual acuity of the worse eye \< 8/10
• Medication that may interfere with binocular vision and/or accommodation
• Accommodation paralysis
• Ocular comorbidity likely to reduce visual acuity
• History of vestibular migraines, vestibular disorders
• History of ocular or systemic disease, infections/congenital malformations
• Neurological history: stroke, head trauma, tumors, epilepsy or neurodegenerative disorders
• Specific learning disability
• Developmental delay (global, language, learning) likely to interfere with treatment or evaluation.
• Failure to obtain written informed consent after a period of reflection
• Not being affiliated to a French social security scheme or benefiting from such a scheme

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

MeSH Terms

Conditions

Eye Diseases; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases

Central Study Contacts

Marie-Céline Mrs. LORENZINI, Dr

CONTACT

04 67 33 50 17; marie-celine.lorenzini@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, randomized, controlled, non-inferiority, open-label study with blinded assessment of primary endpoint.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: September 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share