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Amblyoptica Clinical Trial Criteria

Amblyopia is a neurodevelopmental disorder of vision typically manifesting as reduced visual acuity in one eye and abnormal binocular function.

Amblyopia is a neurodevelopmental disorder of vision typically manifesting as reduced visual acuity in one eye and abnormal binocular function.

Amblyopia is a neurodevelopmental disorder of vision typically manifesting as reduced visual acuity in one eye and abnormal binocular function. Current treatments for amblyopia are usually administered in childhood and include occlusion or “patching”.

This trial involves treatment using a prototype device (the Amblyoptica device) The device is worn in a manner like spectacles. The purpose of this trial is to assess if there is any improvement in visual acuity and binocular function in people with amblyopia (Lazy Eye).

Criteria

Inclusion Criteria

  • Participants should be between 8 and 50 years of age, with a history of previous, but not current, active treatment for amblyopia associated with anisometropia and/or strabismus.
  • Unilateral amblyopia best-corrected visual acuity 6/12 to 6/60 inclusive, fellow eye ≤6/7.5.
  • Anisometropia defined as a spherical equivalent difference of ≥0.50 D between the eyes, or a difference of astigmatism in any meridian ≥1.50D.
  • Strabismus defined as a manifest heterotropia at distance and/or near, or a history of strabismus surgery, or a history of strabismus resolved by hyperopic spectacle correction.

Exclusion Criteria

  • Exclusion criteria include myopia spherical equivalent greater than -6D in either eye, intraocular surgery, ocular pathology or neurological conditions.  For example, optic nerve hypoplasia.

Age Range

8 years

Gender

Both

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