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

November 27, 2022 updated by: Suha Ahmed Amin, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction 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. Amblyopic eyes may have decreased contrast sensitivity and accommodation deficit. The fellow eye is not often normal but has subtle deficits.This can be explained by interocular suppression, or inhibition of the amblyopic eye by the strong eye, with psychophysical and physiological evidence.

Amblyopia can be classified as follows: 1) Strabismic occurring in early childhood 2) Refractive: a) Anisometropic b) High bilateral refractive errors 3) Visual deprivation.

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) approach which is independent of age and type of amblyopia. Furthermore, it has been shown recently that therapy promotes binocular vision by strengthening stereopsis and reducing suppression.

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.

Aim of the work:

To compare the gold standard occlusion therapy alone with dichoptic therapy

Patients and Methods:

Design:

The study will be a prospective experimental controlled study.

Patients of the study:

From the vicinity of the ophthalmology outpatient clinic of Ain Shams University Hospital, 100 patients of both sexes with amblyopia will be enrolled to this study. Informed consents will be obtained from adult patients and children's parents.

Patients will be assigned randomly into two groups:

Group A: 50 patients will receive the gold standard occlusion therapy

Group B: 50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.

Each group will be subdivided according to age:

  1. From 4 to 7 years.
  2. From above 7 to 12 years.
  3. From above 12 to 30 years.

Hours of occlusion will be classified according to the degree of amblyopia:

  • Mild to moderate amblyopia (Best corrected visual acuity (BCVA)< 0.2): 2-4 hours occlusion
  • Severe (BCVA> 0.2): 4-6 hours occlusion

Hours of dichoptic treatment in group B will be classified according to the degree of amblyopia:

  • Mild to moderate amblyopia (BCVA< 0.2): 2-4 hours of treatment
  • Severe (BCVA> 0.2): 4-6 hours of treatment

Methods

All patients will undergo the following:

  1. Full medical and ophthalmic history
  2. Examination:

A) External Appearance:

Anomalous Head Position, globes (e.g., proptosis), lids (e.g. ptosis).

B) Refraction:

With and without cyclopegia

C) Visual acuity:

With and without correction using Snellen acuity chart and preferential looking test for non-verbal patients.

D) Motility:

Ductions and versions (9 positions of gaze) E) Angle of deviation if any

F) Fixation :

Fixation behavior (fixation preference) will be tested via base down 10 prism diopter fixation preference test.

G) Quantitative Binocular vision assessment H) Anterior segment examination. I) Posterior segment examination using indirect ophthalmoscopy with a 20 diopter lens through a dilated pupil.

All patients in Group A will receive the gold standard occlusion therapy. All patients in Group B will receive dichoptic treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals (Demerdash)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any degree of amblyopia
  • Orthotropia in primary position.

Exclusion Criteria:

  • Any ocular disease affecting vision
  • Angle of deviation in primary position (Heterotropia)
  • Adult patients and children's parents unwilling to enter or complete the study
  • Ignorance of patients to use the video game

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
50 patients will receive the gold standard occlusion therapy
Device: eye patch
Occluding the better seeing eye for a given number of hours daily
Experimental: Group B
50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.
Device: dichoptic treatment
dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: 6 months
Best corrected visual acuity in the amblyopic eye
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 6 months
Compliance of the patient to treatment
6 months
crowding ratio
Time Frame: 6 months
crowded vs uncrowded visual acuity
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Hazem H Nouh, MD, Ophthalmology department, faculty of medicine, Ain Shams University
  • Study Chair: Mohammad A Rashad, MD, Ophthalmology department, faculty of medicine, Ain Shams University
  • Study Director: Walid M El-Zawahry, MD, Ophthalmology department, faculty of medicine, Ain Shams University
  • Study Director: Ahmad T Ismail, MD, Ophthalmology department, faculty of medicine, Ain Shams University
  • Principal Investigator: Suha A Hussein, M.Sc, Ophthalmology department, faculty of medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2016

Primary Completion (Actual)

November 27, 2022

Study Completion (Actual)

November 27, 2022

Study Registration Dates

First Submitted

August 6, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 27, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 293/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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