A randomized clinical trial of a new binocular treatment for amblyopia (lazy eye)

Not Applicable

Completed

• Conditions: Amblyopia; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12613001004752
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

* Amblyopia associated with the presence or history of strabismus, anisometropia or both (mixed mechanism).
* Unilateral amblyopia, defined as best corrected visual acuity (VA) in the amblyopic eye of 0.3-1.0 logMAR inclusive, measured using the E-ETDRS protocol from the Electronic Visual Acuity (EVA) testers, VA in the fellow eye equal to or less than 0.1 logMAR and an interocular VA difference equal to or greater than 0.2 log units
* Strabismic amblyopia, defined as amblyopia in the presence of heterotropia distance and/or near fixation, a history of strabismus surgery, or resolution of misalignment following hyperopic spectacle correction, with a spherical equivalent difference < 1.00D between the eyes and a difference in astigmatism in any meridian < 1.50D between the eyes
* Anisometropic amblyopia, defined as amblyopia in the presence of a spherical equivalent difference equal to or greater than 0.50D between the eyes, or a difference of astigmatism in any meridian equal to or greater than 1.50D
* Mixed mechanism amblyopia, defined as amblyopia in the presence of a heterotropia at distance and/or near fixation, a history of strabismus surgery, or a history of resolution of misalignment following a hyperopic spectacle correction and a spherical equivalent difference equal to or greater than 1.00D between the eyes or a difference in astigmatism in any meridian equal to or greater than 1.50D between the eyes
* An ability to align the images shown to each eye on the iPod device under normal binocular viewing conditions in order to successfully play the game as part of their treatment
* Refractive corrections meet the following criteria and are based on a cycloplegic refraction that is not more than six months old (a new cycloplegic refraction will be provided if necessary): 1) Hypermetropia will not be under-corrected by more than +1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. 2) Spherical equivalent power will be equal to or less than +/-0.50D of fully correcting the anisometropia. 3) Cylinder power in each eye will be equal to or less than +/-0.50D of fully correcting the astigmatism for each eye. 4) Cylinder axis in the spectacle lenses in both eyes must be equal to or less than +/-6 degrees of the axis of the cycloplegic refraction when cylinder power is equal to or greater than 1.00 D. Spectacles meeting the above criteria will have been worn either for 16 weeks prior to the baseline visit or until visual acuity is stable (a change equal to or less than 0.1 log units over two measurements made at least four weeks apart) through the refractive adaptation period in this study
* Willing and being able to provide written informed consent for participation in the study

Exclusion Criteria

Myopia > 6.00D, previous intraocular surgery, any co-existent ocular pathology, known neurological anomalies and an inability to align the images shown to each eye on the iPod device.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post-randomisation, measured using the highly standardised E-ETDRS protocol EVA testing system [From baseline to 6 weeks post-randomisation]