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Dichoptic Treatment vs. Patching for Moderate Anisometropic Amblyopia

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ClinicalTrials.gov Identifier: NCT04302701
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Awadein, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Amblyopia Anisometropia Other: Dichoptic treatment using virtual reality Other: Patching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patching Versus Dichoptic Stimulation Using Virtual Reality in Anisometropic Amblyopia
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: Dichoptic arm
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: 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.

Active Comparator: 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. Adherence to the treatment protocol will be assessed by having the parent call / send a message to an investigator at the start and end of the occlusion sessions completed each day, thus making the most as accurate as possible assessment of the patient's adherence to the prescribed treatment
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.




Primary Outcome Measures :
  1. Visual acuity at 10 weeks [ Time Frame: 10 weeks ]
    Change in amblyopic eye VA letter score from baseline to 10 weeks.


Secondary Outcome Measures :
  1. Compliance to treatment [ Time Frame: 10 weeks ]
    Average number of hours of completed treatment in both groups defined as number of hours of completed dichoptic treatment in the dichootic group and number of hours of patching as self reported by patients in the patching group

  2. Number of patients developing misalignment [ Time Frame: 10 weeks ]
    Number of patients developing misalignment after 10 weeks of therapy will be assessed

  3. Regression of amblyopic eye visual acuity [ Time Frame: 20 weeks ]
    Amblyopic eye visual acuity letter score 10 weeks after cessation of treatments

  4. Changes in visual acuity in the sound eye [ Time Frame: 10 weeks ]
    Change in sound eye VA letter score from baseline to 10 weeks.

  5. Changes in near stereopsis [ Time Frame: 10 weeks ]
    Stereopsis using TNO test will be assessed



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Ages Eligible for Study:   6 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with anisometropic amblyopia who had proper optical correction using spectacles or contact lenses for the past 6 weeks. Anisometropic amblyopia will be defined as difference > 0.3 logMAR lines in best-corrected visual acuity with difference in the spherical equivalent of both eyes > 1 D, in the absence of other causes for amblyopia such as organic causes, or manifest strabismus < 5 PD by simultaneous prism and cover test. Patients will be included in the study only if they had no treatment for amblyopia for the past month other than spectacles and/or contact lenses.

Exclusion Criteria:

  • Patients with development delay
  • Prior ocular surgery
  • Co-existing ocular disease
  • Patients with allergy to patch material
  • History of problems with prior use of virtual reality systems
Additional Information:
Publications:
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Responsible Party: Ahmed Awadein, Professor of Ophthalmology, Cairo University
ClinicalTrials.gov Identifier: NCT04302701    
Other Study ID Numbers: Dichoptic-123
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD data will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: after 3 years
Access Criteria: The principal investigator will review requests for information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Anisometropia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Refractive Errors