Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT06049459
Eligibility Criteria:
Inclusion Criteria:
Patients ages 5 to 17 years of age
* Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
* Age normal VA in the nonamblyopic eye
* Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
* Interocular difference of ≥ 3 lines
* No amblyopia treatment in the past 2 weeks
* An interpupillary distance of 52-72 mm (inclusive)
Exclusion Criteria:
* Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
* Previous intraocular or refractive surgery.
* Previous dichoptic treatment \> 2 weeks in duration
* Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
* Diplopia more than once per week over the last week prior to enrollment by parental report.
* Down syndrome or cerebral palsy.
* Light-induced seizures
* Known simulator sickness
* Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT06049459
Study Brief:
Protocol Section:
NCT06049459