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Dichoptic Treatment vs. Patching for Moderate Anisometropic Amblyopia

NCT04302701 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-03-10

No results posted yet for this study

Summary

Recently, there has been an increased interest in evaluating binocular therapies (e.g perceptual learning and dichoptic treatment) for amblyopia. They are designed to improve amblyopia through binocular stimulation by unlocking binocular visual function. The objective of the study is to compare the visual and sensory outcome of 2-hour patching to dichoptic stimulation using virtual reality head mounted display in the management of patients with moderate anisometropic amblyopia. The investigators will include children older than 6 years and adults up to the age of thirty five years with anisometropic amblyopia who either had no prior treatment for amblyopia or had prior treatment for amblyopia using patching therapy but with residual amblyopia defined as \>= 0.3 logMAR lines between the best-corrected visual acuity in the sound eye and in the amblyopic eye and with moderate amblyopia in the more anisometropic eye defined as best-corrected visual acuity better than 6/60 but =\< 6/18. Patients will be randomized into 2 groups according to age using stratified randomization:

* Group P: (Patching Group): This group will have 2 hours of patching each day for 10 weeks.
* Group D (Dichoptic Group): This group will have 1 hour of dichoptic stimulation using the virtual reality system twice a week for 10 weeks for a total of 20 hours of training.

Conditions

  • Amblyopia
  • Anisometropia

Interventions

OTHER

Dichoptic treatment using virtual reality

Dichoptic visual training will be performed with the patient wearing his spectacles using the computer game included in Vivid Vision (Vivid Vision, San Francisco, USA) which will be run in the Oculus Rift OC CV1 virtual reality head mounted display (Oculus VR, Menlo Park, California, USA). Each subject will have 20 treatment sessions, divided into 1 hour-sessions performed twice a week for 10 weeks. Each session will be 60 minutes. Adherence to the treatment regimen will be assessed by the number of hours spent in training at the end of 5th week.

OTHER

Patching

Patients in the control group will be instructed to continue wearing spectacles if required. Patients will be prescribed two continuous hours of daily patching with at least one hour of near activities during patching. Adhesive skin patches will be provided by the study. The parent/patient will be instructed to spend at least one of the hours of patching time each day performing eye-hand coordination activities at near.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-09-30
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04302701 on ClinicalTrials.gov