AmblyopiaNCT05714449
OCT Eccentric Fixation and Amblyopia in Children
A study testing eye patch and After-image and MIT trainer in people with Amblyopia, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- eye patch and After-image and MIT trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 24 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines,
- ocular causes of amblyopia that were identified as refractive(i.e., anisometropic, strabismus, or strabismic-anisometropic.
- Anisometropia included interocular difference of spherical equivalent >=1D or interocular difference of astigmatism cylinder magnitude >=1D;
- strabismus included those with deviation >=10PD or good alignment after prior strabismus surgery;
- combined type included those who meet the criteria of both anisometropia and strabismus.
- For the patching group, we will enroll 15 children with strabismic amblyopia who are prescribed patching treatment. Age: 4-12 years old.
- For the foveation therapy group, we will enroll 15 children with strabismic amblyopia who are prescribed foveation therapies. Age: 8-16 years old.
Who cannot join
- born before 32 weeks gestational age;
- neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;
- congenital or acquired macular pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SUNY College of Optometry
New York, New York, 10036
Jingyun Wang
About this study
Official title: OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children
The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.
Read the detailed description
Aim 1. OCT EF changes with patching treatment at 12 weeks visit.
Aim 2. OCT EF changes with foveation therapy.
- Conditions
- Amblyopia
- Being tested
- eye patch, After-image and MIT trainer
- Keywords
- eccentric fixation, amblyopia, patching, foveation therapy, OCT
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye patchDevice
standard amblyopia treatment
After-image and MIT trainerDevice
Common clinical training for foveation
| Study group | Role | What they receive |
|---|---|---|
| Patching group | Experimental | part-time patching following PEDIG guidelines. Receives: Device: eye patch |
| foveation therapy | Experimental | After-image foveation therapy training is 10 mins; MIT training is 5 minutes. Receives: Device: After-image and MIT trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT eccentric fixation
eccentric fixation measured with OCT imaging.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start25 Jan 2023
- Primary completion24 Feb 2027 (estimated)
- Study completion24 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyun Wang, State University of New York College of Optometry
- Investigators
- Jingyun Wang, Principal investigator, SUNY College of Optmetry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714449
- Sponsor's protocol ID
- 1912342
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children
- ClinicalTrials.gov ID
- NCT05714449
- Acronym / sponsor ID
- 1912342
- Conditions
- Amblyopia
- Keywords
- eccentric fixation, amblyopia, patching, foveation therapy, OCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 6 Feb 2023 (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.
The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.
Detailed description
Aim 1. OCT EF changes with patching treatment at 12 weeks visit.
Aim 2. OCT EF changes with foveation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patching group | Experimental | Device: eye patchpart-time patching following PEDIG guidelines. |
| foveation therapy | Experimental | Device: After-image and MIT trainerAfter-image foveation therapy training is 10 mins; MIT training is 5 minutes. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines,
- ocular causes of amblyopia that were identified as refractive(i.e., anisometropic, strabismus, or strabismic-anisometropic.
Key exclusion criteria (3 listed)
- born before 32 weeks gestational age;
- neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;
- congenital or acquired macular pathology.
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 |
|---|---|---|
| eye patchstandard amblyopia treatment | Device | Patching group |
| After-image and MIT trainerCommon clinical training for foveation | Device | foveation therapy |
Primary outcome
OCT eccentric fixation
Time frame: 12 weeks
eccentric fixation measured with OCT imaging.
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 8 Oct 2026.
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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.
Jingyun Wang principal investigator
SUNY College of Optmetry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye patch and After-image and MIT trainer in people with Amblyopia, run by State University of New York College of Optometry at 1 site in United States.
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 3 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 8 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 United States. 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 Jingyun Wang, PhD (2129385759, jwang@sunyopt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT eccentric fixation (time frame: 12 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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.