Multimodal Therapy in Anisometropic Amblyopia

NCT07093840 | Completed DMC

• 1 other identifier: E-10840098-772.02-5860
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

amblyopia; anisometropia; digital therapy; visual acuity; stereopsis; oculomotor function; motor skills; postural- balance

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (1)

• Stereopsis (Stereoacuity)

  Baseline, 1 month, 3 months, and 6 months

Other Outcomes (3)

• Oculomotor Function

  Baseline, 1 month, 3 months, and 6 months

• Postural Stability (Sensory Organization Test - CDP)

  Baseline, 1 month, 3 months, and 6 months

• Visual-Motor Integration (BOT-2)

  Baseline, 1 month, 3 months, and 6 months

Interventions

AmblyoPlay Digital Visual Therapy DEVICE

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

Also known as: AmblyoPlay,, AmblyoPlay Vision Therapy, Multimodal Visual Therapy

control group OTHER

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 Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yusa Basoglu: lead
• Smartoptometry: collaborator
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, BEYKOZ, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amblyopia; Anisometropia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Istanbul Medipol University

Model Details: Participants were assigned to one of two parallel groups in a non-randomized manner: an intervention group that received AmblyoPlay-based visual therapy for 6 months, and a control group that did not receive any intervention. Group assignment was based on participant availability and preference. Both groups were assessed at baseline, 1st, 3 months, and 6 months using standardized visual, oculomotor, and balance measures.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 29, 2023
• Primary Completion: May 6, 2025
• Study Completion: June 23, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: IPD will be available beginning 6 months after publication of the primary manuscript and will remain available for 5 years.
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access to the de-identified individual participant data (IPD), including the study protocol, statistical analysis plan, informed consent form, and analytic code. Requests must be submitted via email to the principal investigator at ybasoglu@medipol.edu.tr. Each request will be reviewed for scientific merit and compliance with ethical standards. A data use agreement may be required prior to access.

Locations

TU (1)