AmblyopiaNCT07240311
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia
A study testing AmblyoFix binocular digital therapy and Occlusion therapy (Patching) in people with Amblyopia, run by Eyesight Electronics at 1 site in Iran.
Trial summary
This is a prospective, randomized, parallel-group, assessor-masked, non-inferiority clinical trial designed to compare the efficacy, safety, and adherence of AmblyoFix binocular digital therapy with standard occlusion (patching) for the treatment of unilateral amblyopia in children and young adults aged 8 to 19 years. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- AmblyoFix binocular digital therapy and Occlusion therapy (Patching)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2025to 24 Feb 2026
- 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 8 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-19 years.
- Unilateral amblyopia secondary to anisometropia, strabismus, or mixed.
- 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) for AmblyoFix arm.
- Parent/guardian consent and child assent (8+ 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.
Iran1 site
Nour Pajouhan Shargh Eye Specialist Clinic
Zahedan, Sistan & Balouchestan
About this study
Official title: Randomized Controlled Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children, Teenagers and Young Adults Aged 8-19
This is a prospective, randomized, parallel-group, assessor-masked, non-inferiority clinical trial designed to compare the efficacy, safety, and adherence of AmblyoFix binocular digital therapy with standard occlusion (patching) for the treatment of unilateral amblyopia in children and young adults aged 8 to 19 years. In the event that adequate recruitment within this age range is not feasible, the age range may be modified, subject to appropriate ethical approval and protocol amendment procedures.
A total of 40 participants were enrolled. Eligible participants will be randomized in a 1:1 ratio to receive either AmblyoFix or patching, stratified by age group and amblyopia severity. Randomization will be implemented using the sealed opaque envelope method, with allocation concealment maintained through sequentially numbered, tamper-proof envelopes.
Read more
The primary outcome is the change in amblyopic-eye best-corrected visual acuity (BCVA, logMAR) from baseline to 24 weeks, assessed under standardized Snellen or ETDRS protocol. Secondary outcomes include adherence, safety, and patient-reported outcomes. No interim analysis was conducted, as the trial concluded prior to reaching the 12-week time point.
Participants and caregivers cannot be blinded due to the nature of the interventions; however, outcome assessors and statisticians will remain blinded to treatment allocation to minimize bias. Follow-up assessments were conducted at baseline and 4 weeks, representing the time points with complete and reliable data across enrolled participants.
This trial aimed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to standard patching, with the potential to improve adherence and acceptability in amblyopia therapy.
The registered inclusion criteria specified amblyopic-eye BCVA of 0.3 to 1.3 logMAR and an interocular difference of at least 2 lines. Because visual acuity at the study site was recorded in decimal Snellen notation and the threshold was incorrectly converted at screening, participants with amblyopic-eye BCVA of 0.1 to 0.2 logMAR were also enrolled. In addition, for these participants an interocular difference of 1 line was accepted instead of the protocol-specified 2 lines. The 0.3 logMAR threshold had been set because, over the planned 24-week treatment period, participants with milder amblyopia might reach normal acuity before treatment ended; as the trial was terminated with follow-up at 4 weeks, this concern is less relevant to the reported results. The deviation was identified after trial termination and reported to the ethics committee, which on 20 April 2026 (ref. 251/NP/2026) approved inclusion of these participants' data in the analysis.
- Conditions
- Amblyopia
- Being tested
- AmblyoFix binocular digital therapy, Occlusion therapy (Patching)
- 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. The prescribed regimen is 90 minutes per day, six days per week, for 24 weeks. The software incorporates adaptive difficulty adjustment, automated compliance logging with timestamped usage data, and a daily lockout feature to prevent overuse. Therapy adherence and performance are monitored remotely, and caregivers receive structured training materials to support session supervision and troubleshooting.
Occlusion therapy (Patching)Behavioural
Standard occlusion therapy involves patching of the non-amblyopic (fellow) eye to stimulate visual function in the amblyopic eye. Participants are prescribed patching for 2 hours per day, six days per week, over a 24-week treatment period, while continuing to wear their full-time spectacle correction. Caregivers are trained to correctly apply the patch, supervise adherence, and recognize signs of intolerance. Daily patching logs are maintained by caregivers to record hours patched and any issues encountered, and these logs are reviewed by investigators at scheduled follow-up visits.
| 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. Participants will complete 90 minutes of therapy per day, six days per week, for 24 weeks. The software includes adaptive difficulty adjustments, automated usage logging for compliance monitoring, and a daily lockout feature to prevent overuse. Parents/guardians will receive training materials to support session supervision and problem reporting. Receives: Behavioral: AmblyoFix binocular digital therapy |
| Patching (standard occlusion) | Active comparator | Participants assigned to this arm will receive standard occlusion therapy consisting of patching the non-amblyopic eye for 2 hours per day, six days per week, over a 24-week period, while continuing to wear spectacles full time. Caregivers will be trained to correctly apply and monitor patching, maintain daily patching logs documenting hours patched and any issues, and identify signs of intolerance. Patching logs will be reviewed by investigators during scheduled follow-up visits. Receives: Behavioral: Occlusion therapy (Patching) |
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, particularly for the study's target population of individuals aged 8-19 years. 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. Assessments were conducted at baseline and at 4 weeks, representing the time points with complete and reliable data across enrolled participants.
Measured: From enrollment to 4 Weeks
Secondary outcomes (4)
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 available treatment period.
Unit of Measure:
Total minutes of active use per week (minutes/week)
Measured: From enrollment to 4 Weeks
Adherence to occlusion therapy
Adherence will be monitored via parental reporting and a standardized compliance questionnaire administered at clinical visits. Parents will record the average number of hours per day that the prescribed occlusion therapy (eye patching) was completed. A mean reported adherence value will be calculated for each participant, expressed as the ratio of completed to prescribed hours per day.
This questionnaire was developed for this study and has not been previously validated.
Unit of Measure:
Mean hours of occlusion per day (hours/day)
Measured: From enrollment to 4 Weeks
Safety of Amblyofix
Safety will be evaluated by recording all adverse events (AEs) and serious adverse events (SAEs) throughout the available 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 4 Weeks
Patient Satisfaction
Patient satisfaction will be assessed using a custom 10-item questionnaire developed for this study. Each item is rated on a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied). The questionnaire evaluates four domains: acceptability, comfort, ease of use, and overall satisfaction. Scores will be averaged to produce a total satisfaction score, with higher values indicating greater satisfaction.
This instrument was developed specifically for this trial and has not been previously validated.
Due to early trial termination, the patient satisfaction questionnaire was not administered to participants in either arm, as the study did not progress to the scheduled assessment stage at which this measure was to be collected.
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 posted20 Nov 2025
- Study start1 Sep 2025
- Primary completion18 Feb 2026
- Study completion24 Feb 2026
Why it stopped: Early termination due to force majeure, including a prolonged regional internet blackout, initial suspension of the study over security concerns, and a complete halt following the outbreak of war in the region.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyesight Electronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nour Pajouhan Shargh Eye Specialist Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240311
- Sponsor's protocol ID
- AFX-RCT-IRN-2025
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children, Teenagers and Young Adults Aged 8-19
- ClinicalTrials.gov ID
- NCT07240311
- Acronym / sponsor ID
- AFX-RCT-IRN-2025
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to force majeure, including a prolonged regional internet blackout, initial suspension of the study over security concerns, and a complete halt following the outbreak of war in the region.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eyesight ElectronicsIndustry (pharma, biotech, devices)
- Collaborators
- Nour Pajouhan Shargh Eye Specialist Clinic
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 20 Nov 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 is a prospective, randomized, parallel-group, assessor-masked, non-inferiority clinical trial designed to compare the efficacy, safety, and adherence of AmblyoFix binocular digital therapy with standard occlusion (patching) for the treatment of unilateral amblyopia in children and young adults aged 8 to 19 years. In the event that adequate recruitment within this age range is not feasible, the age range may be modified, subject to appropriate ethical approval and protocol amendment procedures.
A total of 40 participants were enrolled. Eligible participants will be randomized in a 1:1 ratio to receive either AmblyoFix or patching, stratified by age group and amblyopia severity. Randomization will be implemented using the sealed opaque envelope method, with allocation concealment maintained through sequentially numbered, tamper-proof envelopes.
The primary outcome is the change in amblyopic-eye best-corrected visual acuity (BCVA, logMAR) from baseline to 24 weeks, assessed under standardized Snellen or ETDRS protocol. Secondary outcomes include adherence, safety, and patient-reported outcomes. No interim analysis was conducted, as the trial concluded prior to reaching the 12-week time point.
Participants and caregivers cannot be blinded due to the nature of the interventions; however, outcome assessors and statisticians will remain blinded to treatment allocation to minimize bias. Follow-up assessments were conducted at baseline and 4 weeks, representing the time points with complete and reliable data across enrolled participants.
This trial aimed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to standard patching, with the potential to improve adherence and acceptability in amblyopia therapy.
The registered inclusion criteria specified amblyopic-eye BCVA of 0.3 to 1.3 logMAR and an interocular difference of at least 2 lines. Because visual acuity at the study site was recorded in decimal Snellen notation and the threshold was incorrectly converted at screening, participants with amblyopic-eye BCVA of 0.1 to 0.2 logMAR were also enrolled. In addition, for these participants an interocular difference of 1 line was accepted instead of the protocol-specified 2 lines. The 0.3 logMAR threshold had been set because, over the planned 24-week treatment period, participants with milder amblyopia might reach normal acuity before treatment ended; as the trial was terminated with follow-up at 4 weeks, this concern is less relevant to the reported results. The deviation was identified after trial termination and reported to the ethics committee, which on 20 April 2026 (ref. 251/NP/2026) approved inclusion of these participants' data in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| 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. Participants will complete 90 minutes of therapy per day, six days per week, for 24 weeks. The software includes adaptive difficulty adjustments, automated usage logging for compliance monitoring, and a daily lockout feature to prevent overuse. Parents/guardians will receive training materials to support session supervision and problem reporting. |
| Patching (standard occlusion) | Active comparator | Behavioral: Occlusion therapy (Patching)Participants assigned to this arm will receive standard occlusion therapy consisting of patching the non-amblyopic eye for 2 hours per day, six days per week, over a 24-week period, while continuing to wear spectacles full time. Caregivers will be trained to correctly apply and monitor patching, maintain daily patching logs documenting hours patched and any issues, and identify signs of intolerance. Patching logs will be reviewed by investigators during scheduled follow-up visits. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 8-19 years.
- Unilateral amblyopia secondary to anisometropia, strabismus, or mixed.
- 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. The prescribed regimen is 90 minutes per day, six days per week, for 24 weeks. The software incorporates adaptive difficulty adjustment, automated compliance logging with timestamped usage data, and a daily lockout feature to prevent overuse. Therapy adherence and performance are monitored remotely, and caregivers receive structured training materials to support session supervision and troubleshooting. | Behavioural | AmblyoFix |
| Occlusion therapy (Patching)Standard occlusion therapy involves patching of the non-amblyopic (fellow) eye to stimulate visual function in the amblyopic eye. Participants are prescribed patching for 2 hours per day, six days per week, over a 24-week treatment period, while continuing to wear their full-time spectacle correction. Caregivers are trained to correctly apply the patch, supervise adherence, and recognize signs of intolerance. Daily patching logs are maintained by caregivers to record hours patched and any issues encountered, and these logs are reviewed by investigators at scheduled follow-up visits. | Behavioural | Patching (standard occlusion) |
Primary outcome
Change in BCVA in the amblyopic eye from baseline to Week 24
Time frame: From enrollment to 4 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, particularly for the study's target population of individuals aged 8-19 years. 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. Assessments were conducted at baseline and at 4 weeks, representing the time points with complete and reliable data across enrolled participants.
4 secondary outcomes
Adherence to AmblyoFix
Time frame: From enrollment to 4 Weeks
Adherence to occlusion therapy
Time frame: From enrollment to 4 Weeks
Safety of Amblyofix
Time frame: From enrollment to 4 Weeks
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 24 Weeks
Results and safety
The study was stopped early (reason given: Early termination due to force majeure, including a prolonged regional internet blackout, initial suspension of the study over security concerns, and a complete halt following the outbreak of war in the region.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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. 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 AmblyoFix binocular digital therapy and Occlusion therapy (Patching) in people with Amblyopia, run by Eyesight Electronics at 1 site in Iran.
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: stopped early, as of the sponsor's last update on 30 Oct 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 Iran. 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 was stopped early (reason given: Early termination due to force majeure, including a prolonged regional internet blackout, initial suspension of the study over security concerns, and a complete halt following the outbreak of war in the region.). Results are not available in the source record.
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?
Change in BCVA in the amblyopic eye from baseline to Week 24 (time frame: From enrollment to 4 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 30 Oct 2026.