NCT03255707

A Comparative Study Between Dissociative Treatment and Binocular Interactive Treatment in Amblyopia

Completed NA Last updated 29 November 2022

What this trial tests

NA trial testing eye patch in Amblyopia in 80 participants. Completed in 27 November 2022.

Timeline

24 November 2016

Primary endpoint
27 November 2022

27 November 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	24 November 2016
Primary completion	27 November 2022
Estimated completion	27 November 2022
Sites	1 location across Egypt

Drugs / interventions tested

• eye patch
• dichoptic treatment

Conditions studied

• Amblyopia — all drugs for Amblyopia →

Sponsor

Ain Shams University

Who can join

Adults 4 to 30, any sex, with Amblyopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amblyopia is a unilateral or, infrequently, a bilateral reduction of best corrected visual acuity which cannot be attributed to coexisting eye or visual pathway disease. Amblyopia can be due to eye-crossing occurring in early childhood or due to error of refraction whether a high difference between the two eyes or very high bilateral refractive errors.Another cause could be visual deprivation like the presence of congenital cataract.

The prevalence of amblyopia worldwide is approximately 1%-5% .In Egypt, a study that was held in Upper Egypt, found that the prevalence of amblyopia was 1.49%, which is higher in rural areas than in urban areas.

Several modalities of treatment for amblyopia are available, yet occlusion treatment is the gold standard involving covering the good eye with a patch for a prescribed period of time ranging from 10 minutes daily to all waking hours. However, its effectiveness decreases in older children and adults.

Disadvantages include prolonged treatment leading to poor compliance, patching related distress, relationship strain and stigma. In extreme cases, non-compliance with patching results in a costly hospital admission to supervise the patching treatment. In addition, wearing a patch eliminates any advantage of binocularity. Not to mention that not all patients respond to patching and of those who do, many have residual amblyopia after treatment is stopped regardless of compliance. More importantly, binocular vision is not automatically restored once the vision in the amblyopic eye has been improved. In fact, once the patch is removed after therapy, the amblyopic eye could be suppressed by the better seeing eye and can lose some of the gains achieved as a result of therapy.

Another modality of treatment is atropine eye drops and optical penalisation which are usually secondary treatments to failed patching but carrying the same disadvantages as the ordinary patching.

Advances in amblyopia treatment include dichoptic training, perceptual learning, and video gaming. These depend on the fact that the adult brain has been shown to be much more plastic than it was once believed to be and hence have the advantage of expanding the age of response in adults.

Perceptual learning approaches have the advantage of being a dichoptic (binocular treatment using both eyes) approach which is independent of age and type of amblyopia.

A step further to conventional treatment is the use of a home-based approach allowing remote internet monitoring of treatment between office visits and hence better compliance. In addition a video game version of the treatment is developed to make it more enjoyable for improving compliance.

Our goal is to compare the outcome between the gold standard occlusion therapy and one of the dichoptic treatments.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Occlusion for stimulus deprivation amblyopia.
   Antonio-Santos A, Vedula SS, Hatt SR, Powell C. · · 2020 · cited 8× · PMID 32203629 · DOI 10.1002/14651858.cd005136.pub4