Ophthalmological DisorderALEDICENCT06465615
Effect of Binocular Treatment Using a Dichoptic Reading Application in Children With Convergence Insufficiency.
A study testing Self-education with dichoptic reading on tablet and Conventional orthoptic rehabilitation in people with Ophthalmological Disorder, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Ophthalmological Disorder
- What is being tested?
- Self-education with dichoptic reading on tablet and Conventional orthoptic rehabilitation
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Ophthalmological check-up performed within 2 months prior to inclusion
- Convergence Insufficiency Symptom Survey (CISS) score ≥ 16
- Convergence punctum proximum ≥ 6 cm
Show all 10Show fewer
- Amplitude of fusion in near convergence ≤ 15 prismatic dioptres or less than 2 times the phoria measured in near vision (Sheard's criterion).
- Best corrected distance and near visual acuity ≥ 20/25 (=8/10) and wearing appropriate refractive correction (glasses or contact lenses) for at least 2 weeks prior to study inclusion.
- 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).
Who cannot join
- Binocular vergence dysfunctions such as constant strabismus
- Prism (unless removed ≥ 2 weeks prior to inclusion)
- 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
Show all 17Show fewer
- 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
- Pregnant or breast-feeding
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
- Conditions
- Ophthalmological Disorder
- Being tested
- Self-education with dichoptic reading on tablet, Conventional orthoptic rehabilitation
- Keywords
- Convergence insufficiency, therapy, Vision, Binocular, physiology, Vision, Monocular, physiology, Depth Perception, physiology, Contrast Sensitivity
- Medical subject headings
- Eye Diseases, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-education with dichoptic reading on tabletDevice
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.
Conventional orthoptic rehabilitationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Conventional orthoptic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: T0 and T3 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T3 weeks ands T6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized, controlled, non-inferiority, open-label study with blinded assessment of primary endpoint.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465615
- Sponsor's protocol ID
- RECHMPL22_0552
- Acronym
- ALEDICE
- Status last verified
- May 2024
- First submitted
- 13 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Binocular Dichoptic Reading Treatment on Visual Function in Children With Symptomatic Convergence Insufficiency: a Pilot Noninferiority Study. ALEDICE
- ClinicalTrials.gov ID
- NCT06465615
- Acronym / sponsor ID
- ALEDICE / RECHMPL22_0552
- Conditions
- Ophthalmological Disorder
- Keywords
- Convergence insufficiency, therapy, Vision, Binocular, physiology, Vision, Monocular, physiology, Depth Perception, physiology, Contrast Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized, controlled, non-inferiority, open-label study with blinded assessment of primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Self-education with dichoptic reading on tabletself-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 | Procedure: Conventional orthoptic rehabilitationThe 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
- Ophthalmological check-up performed within 2 months prior to inclusion
- Convergence Insufficiency Symptom Survey (CISS) score ≥ 16
Key exclusion criteria (17 listed)
- Binocular vergence dysfunctions such as constant strabismus
- Prism (unless removed ≥ 2 weeks prior to inclusion)
- History of recent orthoptic rehabilitation (< 6 months)
- History of intraocular or refractive surgery
- Current amblyopia treatment or treated amblyopia (isoacuity) < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-education with dichoptic reading on tabletIntervention 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. | Device | Experimental group |
| Conventional orthoptic rehabilitationConventional 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). | Procedure or surgery | Control group |
Primary outcome
Evolution of symptoms at the end of the intervention
Time frame: T0 and T6 weeks
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.
Evolution of symptoms halfway through the intervention
Time frame: T0 and T3 weeks
Evolution of symptoms (decrease in Convergence Insufficiency Symptom Survey (CISS) score measured 3 weeks after the start of binocular treatment)
13 secondary outcomes
Evolution of the punctum proximum of convergence (PPC)
Time frame: T0 and T3 weeks and T0 and T6 weeks
Evolution of stereoacuity
Time frame: T0 and T3 weeks and T0 and T6 weeks
Normalization of fusion amplitude in near convergence
Time frame: T0 and T3 weeks ans T0 and T6 weeks
Normalization of punctum proximum of convergence (PPC)
Time frame: T0 and T3 weeks ans T0 and T6 weeks
Evolution of reading speed
Time frame: T0 and T3 weeks ans T0 and T6 weeks
Interocular suppression measured with the Dichoptic Contrast Ordering Test (DICOT)
Time frame: T0 and T3 weeks ans T0 and T6 weeks
Changes in quality of life
Time frame: T0 and T3 weeks ans T0 and T6 weeks
Prevalence of patients with "Complete Response", "Partial Response" and "Nonresponders
Time frame: T3 weeks and T6 weeks
Treatment compliance
Time frame: T3 weeks and T6 weeks
Adherence to self-training
Time frame: T3 weeks and T6 weeks
Visual comfort when using the dichoptic reading application
Time frame: T3 weeks and T6 weeks
Level of certainty of recognition of the patient randomization arm for the evaluating orthoptist
Time frame: T3 weeks and T6 weeks
Adverse events
Time frame: T3 weeks ands T6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Self-education with dichoptic reading on tablet and Conventional orthoptic rehabilitation in people with Ophthalmological Disorder, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Céline Mrs. LORENZINI, Dr (04 67 33 50 17, marie-celine.lorenzini@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of symptoms at the end of the intervention (time frame: T0 and T6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.