Effect of Binocular Dichoptic Reading Treatment on Visual Function in Children With Symptomatic Convergence Insufficiency: a Pilot Noninferiority Study. ALEDICE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Evolution of symptoms at the end of the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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
- •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
研究组 & 干预措施
Experimental group
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).
干预措施: Self-education with dichoptic reading on tablet (Device)
Control group
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.
干预措施: Conventional orthoptic rehabilitation (Procedure)
结局指标
主要结局
Evolution of symptoms at the end of the intervention
时间窗: 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
时间窗: T0 and T3 weeks
Evolution of symptoms (decrease in Convergence Insufficiency Symptom Survey (CISS) score measured 3 weeks after the start of binocular treatment)
次要结局
- Visual comfort when using the dichoptic reading application(T3 weeks and T6 weeks)
- Adverse events(T3 weeks ands T6 weeks)
- Evolution of the punctum proximum of convergence (PPC)(T0 and T3 weeks and T0 and T6 weeks)
- Evolution of reading speed(T0 and T3 weeks ans T0 and T6 weeks)
- Changes in quality of life(T0 and T3 weeks ans T0 and T6 weeks)
- Prevalence of patients with "Complete Response", "Partial Response" and "Nonresponders(T3 weeks and T6 weeks)
- Adherence to self-training(T3 weeks and T6 weeks)
- Evolution of stereoacuity(T0 and T3 weeks and T0 and T6 weeks)
- Treatment compliance(T3 weeks and T6 weeks)
- Normalization of punctum proximum of convergence (PPC)(T0 and T3 weeks ans T0 and T6 weeks)
- Interocular suppression measured with the Dichoptic Contrast Ordering Test (DICOT)(T0 and T3 weeks ans T0 and T6 weeks)
- Level of certainty of recognition of the patient randomization arm for the evaluating orthoptist(T3 weeks and T6 weeks)
- Normalization of fusion amplitude in near convergence(T0 and T3 weeks ans T0 and T6 weeks)