Multimodal Therapy in Anisometropic Amblyopia

NCT ID: NCT07093840

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-29
• Study Completion Date: 2025-06-23

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AmblyoPlay Digital Visual Therapy

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

Intervention Type: DEVICE

control group

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.

Intervention Type: OTHER

Other Intervention Names

AmblyoPlay,; AmblyoPlay Vision Therapy; Multimodal Visual Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smartoptometry

UNKNOWN

Sponsor Role: collaborator

Bağcılar Medipol University Hospital

UNKNOWN

Sponsor Role: collaborator

Yusa Basoglu

OTHER

Sponsor Role: lead

Responsible Party

Yusa Basoglu

Istanbul Medipol University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istanbul Medipol University

Istanbul, BEYKOZ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-5860

Identifier Type: -

Identifier Source: org_study_id