Multimodal Therapy in Anisometropic Amblyopia (MUTA)

Yusa Basoglu

Status: Completed

Conditions: Postural Balance; Vision Therapy; Oculomotor System; Pediatric; Amblyopia, Anisometropic

Treatments: Other: control group; Device: AmblyoPlay Digital Visual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07093840

E-10840098-772.02-5860

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)