Amblyopia, AnisometropicMUTANCT07093840
Multimodal Therapy in Anisometropic Amblyopia
A study testing AmblyoPlay Digital Visual Therapy in people with Amblyopia, Anisometropic and Pediatric, run by Yusa Basoglu at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Anisometropic, Pediatric, Postural Balance
- What is being tested?
- AmblyoPlay Digital Visual Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2023to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, BEYKOZ, 34810
About this study
Official title: Effectiveness of AmblyoPlay-Based Multimodal Therapy in Children With Anisometropic Amblyopia
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.
Read the 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.
- Being tested
- AmblyoPlay Digital Visual Therapy, control group
- Keywords
- amblyopia, anisometropia, digital therapy, visual acuity, stereopsis, oculomotor function, motor skills, postural- balance
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmblyoPlay Digital Visual TherapyDevice
Also called AmblyoPlay,, AmblyoPlay Vision Therapy, Multimodal 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
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (1)
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start29 Jul 2023
- Primary completion6 May 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amblyopia, AnisometropicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yusa Basoglu
- Sponsor type
- University, hospital or other
- Collaborators
- Smartoptometry, Istanbul Medipol University Hospital
- Responsible party
- Sponsor-investigator, Yusa Basoglu, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093840
- Sponsor's protocol ID
- E-10840098-772.02-5860
- Acronym
- MUTA
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results reported in this study (after de-identification) will be made available to researchers upon reasonable request. Data will be shared for the purpose of academic research, including meta-analyses, and must be supported by a methodologically sound proposal. Access to the data will be granted beginning 6 months after publication and will remain available for 5 years. A data dictionary defining each variable will also be provided. Requests should be directed to: ybasoglu@medipol.edu.tr.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of AmblyoPlay-Based Multimodal Therapy in Children With Anisometropic Amblyopia
- ClinicalTrials.gov ID
- NCT07093840
- Acronym / sponsor ID
- MUTA / E-10840098-772.02-5860
- Keywords
- amblyopia, anisometropia, digital therapy, visual acuity, stereopsis, oculomotor function, motor skills, postural- balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yusa BasogluUniversity, hospital or other
- Collaborators
- Smartoptometry, Istanbul Medipol University Hospital
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Model description
- 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.
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmblyoPlay Digital Visual TherapyAlso: AmblyoPlay,, AmblyoPlay Vision Therapy, Multimodal Visual TherapyAmblyoPlay 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 | Device | – |
| control groupParticipants 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. | Other | – |
Primary outcome
Visual acuity
Time frame: Baseline, 1 month, 3 months, and 6 months
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.
1 secondary outcome
Stereopsis (Stereoacuity)
Time frame: Baseline, 1 month, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results reported in this study (after de-identification) will be made available to researchers upon reasonable request. Data will be shared for the purpose of academic research, including meta-analyses, and must be supported by a methodologically sound proposal. Access to the data will be granted beginning 6 months after publication and will remain available for 5 years. A data dictionary defining each variable will also be provided. Requests should be directed to: ybasoglu@medipol.edu.tr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmblyoPlay Digital Visual Therapy in people with Amblyopia, Anisometropic and Pediatric, run by Yusa Basoglu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.