Multimodal Therapy in Anisometropic Amblyopia

Yusa Basoglu29 enrolled

Overview

This study aims to evaluate whether a six-month app-based visual therapy program, called AmblyoPlay, can improve visual acuity, oculomotor skills, and balance in children with anisometropic amblyopia (a type of "lazy eye" caused by unequal refractive errors between the eyes). The therapy uses interactive games to train visual and motor functions. The study compares children who receive this therapy with a control group of children who do not receive any intervention. Researchers aim to explore the effectiveness of a multidisciplinary, technology-assisted approach that addresses visual and sensorimotor functions through an integrated, child-centered perspective.

This study investigates the effects of a six-month, app-based multimodal visual therapy program-AmblyoPlay-on visual acuity, oculomotor skills, hand-eye coordination, and postural control in children diagnosed with anisometropic amblyopia. Unlike traditional approaches that focus solely on monocular visual improvement, this study adopts a multidimensional, integrative framework that engages both visual and sensorimotor systems through gamified, child-friendly digital exercises. The intervention is grounded in principles of dichoptic stimulation and neuroplasticity, aiming to reduce interocular suppression while promoting binocular cooperation. Through real-time adaptive difficulty algorithms, AmblyoPlay delivers personalized visual-motor challenges tailored to the developmental level of each participant. Assessments are conducted at multiple time points to track progression across visual, motor, and postural domains. A control group of age- and sex-matched children with normal development is used for comparative analysis. This study is designed to contribute evidence on the feasibility and efficacy of a multidisciplinary therapeutic model for pediatric amblyopia, highlighting the importance of addressing not only visual deficits but also associated functional impairments in balance and coordination.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

Interventions

AmblyoPlay Digital Visual TherapyDEVICE

AmblyoPlay is a home-based, app-delivered multimodal visual therapy program designed for children with amblyopia. The therapy consisted of 30-minute sessions, performed 5 days per week over a 6-month period. Exercises included gamified visual tasks targeting oculomotor control, visual acuity, stereopsis, visual-motor integration, and postural coordination. The software automatically adjusted task difficulty based on individual performance. Therapy was performed on a tablet or computer with red-green anaglyph glasses provided to participants

control groupOTHER

Participants in this group were healthy children who did not receive any therapeutic intervention during the 6-month study period. They were age- and gender-matched with participants in the intervention group to ensure baseline comparability. Assessments were performed only at baseline and at the 6-month follow-up and included measurements of visual acuity, oculomotor function, stereopsis, visual-motor integration, and postural control.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 7 and 13 years Diagnosed with anisometropic amblyopia according to AAO (American Academy of Ophthalmology) guidelines No vestibular pathology within the past 6 months No cognitive or mental impairments No history of prior ophthalmologic treatment for amblyopia Able to adhere to the treatment protocol Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Age outside the range of 7 to 13 years Presence of strabismus or other ocular pathologies (e.g., cataract, retinal disease) Diagnosed neurological, developmental, or psychiatric disorders Use of medications that may affect vision or balance Participation in another clinical trial within the past 6 months Inability to attend scheduled follow-up evaluations or comply with study procedures

Outcomes

Primary Outcomes

Visual acuity

Visual acuity (VA) was assessed using a standard Snellen chart under both monocular and binocular viewing conditions. Participants were instructed to read optotypes from a distance of 6 meters for distance vision and 40 cm for near vision. Each eye was tested separately, followed by binocular testing. The smallest optotype correctly identified was recorded as the VA score. Results were documented in Snellen fractions and converted to decimal values for statistical analysis (e.g., 20/20 = 1.0; 20/40 = 0.5; 20/100 = 0.2). Higher decimal values represented better visual acuity.

Time frame: Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes

Stereopsis (Stereoacuity)

Stereoscopic vision was assessed using the Titmus Stereo Test. Participants wore polarized glasses and viewed the test booklet from a distance of approximately 40 cm. The test required identification of three-dimensional figures, including the fly, animal shapes, and Wirt circles. The stereoacuity threshold was recorded in arc seconds (arc-sec) based on the smallest disparity level correctly perceived. Scores were categorized as gross stereopsis (3600 arc-sec), moderate stereoacuity (800-200 arc-sec), and fine stereoacuity (100-40 arc-sec). Lower arc-sec values indicated better depth perception.