AmblyopiaNCT07323953
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
A study testing AmblyoFix binocular digital therapy in people with Amblyopia, run by Eyesight Electronics at 1 site in Egypt.
Trial summary
This is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- AmblyoFix binocular digital therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2026to 16 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-12 years.
- Unilateral amblyopia secondary to anisometropia and/or mild strabismus.
- BCVA in amblyopic eye between 20/40-20/400 (0.3-1.3 logMAR); fellow eye ≥20/32 (≤0.2 logMAR).
- Interocular difference ≥2 lines (≥0.2 logMAR).
- Stable refractive correction for ≥16 weeks or <0.1 logMAR change across two visits ≥8 weeks apart.
- Cycloplegic refraction within 7 months meeting anisometropia criteria (e.g., hyperopia ≥+2.50 D).
- Access to a suitable home environment (laptop and internet).
- Parent/guardian consent and child assent (7+ year olds).
Who cannot join
- Atropine use within 2 weeks before starting treatment
- Prior amblyopia treatment beyond refractive adaptation.
- Myopia >-6.00 D SE, previous ocular surgery, or other ocular pathology.
- Severe cognitive/developmental delay impeding compliance.
- History of light-induced seizures.
- Inability/unwillingness to comply with digital monitoring.
- Any condition compromising safety or trial integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Watany Research and Development Center, Watany Eye Hospital
Cairo
Dr. Mohamed El Bahrawy, +2012260616112, int.dept@watanyeyehospitals.com
Dr. Heba Fuoad, MD, PhD Ophthalmology
About this study
Official title: Prospective Clinical Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children
This is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Outcomes will be compared against a retrospective cohort of patients of the same age range previously treated with standard occlusion (patching) at the same clinic.
A total of 33 participants will be enrolled, allowing for up to 15% attrition to ensure at least 28 evaluable completers at Week 24. Eligible participants must have unilateral amblyopia with amblyopic-eye best-corrected visual acuity (BCVA) between 0.3 and 1.3 logMAR and an interocular difference of at least 0.2 logMAR, with stable refractive correction for at least 16 weeks prior to enrollment.
Read more
The primary outcome is the change in amblyopic-eye BCVA (logMAR) from baseline to Week 24, assessed under standardized Snellen or ETDRS protocol by certified, masked outcome assessors. Secondary outcomes include adherence (captured via in-software usage logs), safety (BCVA worsening ≥2 lines and ocular adverse events), and patient-reported outcomes (acceptability, usability, satisfaction). An interim analysis will be conducted at Week 6 and at Week 12 to review early efficacy and safety, with the option to recommend early termination if robust evidence of non-inferiority is demonstrated.
In addition to the primary study population of unilateral amblyopia, an exploratory subgroup of 3 or more participants with bilateral amblyopia may be enrolled for observational evaluation. Treatment will initially target the eye with worse BCVA as selected in the AmblyoFix software. Upon sufficient improvement, as determined by the Principal Investigator, treatment may be switched to the other eye within the software settings. Data from the bilateral exploratory cohort will be analyzed descriptively and reported separately. These data will not contribute to the primary non-inferiority analysis.
Participants and caregivers cannot be blinded due to the nature of the intervention; however, outcome assessors and statisticians will remain masked to study objectives and comparator data to minimize bias. Follow-up assessments will occur at baseline, Week 6, Week 12, and Week 24, with no additional amblyopia treatment permitted during the study unless clinically required.
This trial is designed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to patching, with the potential to improve adherence, usability, and acceptability in real-world amblyopia therapy.
- Conditions
- Amblyopia
- Being tested
- AmblyoFix binocular digital therapy
- Keywords
- Amblyopia Treatment
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmblyoFix binocular digital therapyBehavioural
AmblyoFix is a binocular vision therapy delivered through specialized software on a laptop computer in combination with red-blue anaglyph glasses. The program uses interactive, gamified visual tasks designed to stimulate the amblyopic eye while maintaining binocular viewing conditions. Each participant undergoes a standardized calibration process to ensure screen specifications are validated before starting therapy.
| Study group | Role | What they receive |
|---|---|---|
| AmblyoFix | Experimental | Participants assigned to this arm will undergo binocular vision therapy using the AmblyoFix software on a laptop, in combination with red-blue anaglyph glasses. Prior to therapy initiation, a calibration process will be completed and validated by the study team to ensure device screen specifications meet protocol requirements. Treatment consists of interactive, gamified visual tasks designed to stimulate the amblyopic eye under binocular viewing conditions. Receives: Behavioral: AmblyoFix binocular digital therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA in the amblyopic eye from baseline to Week 24
The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized.
Measured: From enrollment to the end of treatment at 24 Weeks
Secondary outcomes (2)
Adherence to AmblyoFix
Adherence will be objectively measured through the AmblyoFix software's built-in time-tracking functions, which automatically record session frequency and duration. Adherence will be calculated as the total minutes of active use per week compared with the prescribed target duration. Mean weekly adherence will be derived over the 24-week treatment period.
Unit of Measure: Total minutes of active use per week (minutes/week)
Measured: From enrollment to the end of treatment at 24 Weeks
Safety of Amblyofix
Safety will be evaluated by recording all adverse events (AEs) and serious adverse events (SAEs) throughout the 24-week intervention period. Particular attention will be paid to ocular health, including reports of visual discomfort, diplopia, or any unexpected effects potentially related to digital therapy or occlusion. All safety data will be reviewed and summarized by the study investigators at each follow-up visit and at study completion. Unit of Measure: Number of participants with adverse events.
Measured: From enrollment to the end of treatment at 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Mar 2026
- Primary completion25 Feb 2027 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eyesight Electronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al Watany Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323953
- Sponsor's protocol ID
- AFX-PCT-EG-2025
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children
- ClinicalTrials.gov ID
- NCT07323953
- Acronym / sponsor ID
- AFX-PCT-EG-2025
- Conditions
- Amblyopia
- Keywords
- Amblyopia Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Eyesight ElectronicsIndustry (pharma, biotech, devices)
- Collaborators
- Al Watany Eye Hospital
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 7 Jan 2026 (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 is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Outcomes will be compared against a retrospective cohort of patients of the same age range previously treated with standard occlusion (patching) at the same clinic.
A total of 33 participants will be enrolled, allowing for up to 15% attrition to ensure at least 28 evaluable completers at Week 24. Eligible participants must have unilateral amblyopia with amblyopic-eye best-corrected visual acuity (BCVA) between 0.3 and 1.3 logMAR and an interocular difference of at least 0.2 logMAR, with stable refractive correction for at least 16 weeks prior to enrollment.
The primary outcome is the change in amblyopic-eye BCVA (logMAR) from baseline to Week 24, assessed under standardized Snellen or ETDRS protocol by certified, masked outcome assessors. Secondary outcomes include adherence (captured via in-software usage logs), safety (BCVA worsening ≥2 lines and ocular adverse events), and patient-reported outcomes (acceptability, usability, satisfaction). An interim analysis will be conducted at Week 6 and at Week 12 to review early efficacy and safety, with the option to recommend early termination if robust evidence of non-inferiority is demonstrated.
In addition to the primary study population of unilateral amblyopia, an exploratory subgroup of 3 or more participants with bilateral amblyopia may be enrolled for observational evaluation. Treatment will initially target the eye with worse BCVA as selected in the AmblyoFix software. Upon sufficient improvement, as determined by the Principal Investigator, treatment may be switched to the other eye within the software settings. Data from the bilateral exploratory cohort will be analyzed descriptively and reported separately. These data will not contribute to the primary non-inferiority analysis.
Participants and caregivers cannot be blinded due to the nature of the intervention; however, outcome assessors and statisticians will remain masked to study objectives and comparator data to minimize bias. Follow-up assessments will occur at baseline, Week 6, Week 12, and Week 24, with no additional amblyopia treatment permitted during the study unless clinically required.
This trial is designed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to patching, with the potential to improve adherence, usability, and acceptability in real-world amblyopia therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AmblyoFix | Experimental | Behavioral: AmblyoFix binocular digital therapyParticipants assigned to this arm will undergo binocular vision therapy using the AmblyoFix software on a laptop, in combination with red-blue anaglyph glasses. Prior to therapy initiation, a calibration process will be completed and validated by the study team to ensure device screen specifications meet protocol requirements. Treatment consists of interactive, gamified visual tasks designed to stimulate the amblyopic eye under binocular viewing conditions. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 7-12 years.
- Unilateral amblyopia secondary to anisometropia and/or mild strabismus.
- BCVA in amblyopic eye between 20/40-20/400 (0.3-1.3 logMAR); fellow eye ≥20/32 (≤0.2 logMAR).
- Interocular difference ≥2 lines (≥0.2 logMAR).
- Stable refractive correction for ≥16 weeks or <0.1 logMAR change across two visits ≥8 weeks apart.
Key exclusion criteria (7 listed)
- Atropine use within 2 weeks before starting treatment
- Prior amblyopia treatment beyond refractive adaptation.
- Myopia >-6.00 D SE, previous ocular surgery, or other ocular pathology.
- Severe cognitive/developmental delay impeding compliance.
- History of light-induced seizures.
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 |
|---|---|---|
| AmblyoFix binocular digital therapyAmblyoFix is a binocular vision therapy delivered through specialized software on a laptop computer in combination with red-blue anaglyph glasses. The program uses interactive, gamified visual tasks designed to stimulate the amblyopic eye while maintaining binocular viewing conditions. Each participant undergoes a standardized calibration process to ensure screen specifications are validated before starting therapy. | Behavioural | AmblyoFix |
Primary outcome
Change in BCVA in the amblyopic eye from baseline to Week 24
Time frame: From enrollment to the end of treatment at 24 Weeks
The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized.
2 secondary outcomes
Adherence to AmblyoFix
Time frame: From enrollment to the end of treatment at 24 Weeks
Safety of Amblyofix
Time frame: From enrollment to the end of treatment at 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmblyoFix binocular digital therapy in people with Amblyopia, run by Eyesight Electronics at 1 site in Egypt.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Heba Fuoad, MD, PhD Ophthalmology (+2012260616112, hebamfouad@watanyeyehospitals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BCVA in the amblyopic eye from baseline to Week 24 (time frame: From enrollment to the end of treatment at 24 Weeks). 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 23 Sep 2026.