Dichoptic Treatment vs. Patching for Moderate Anisometropic Amblyopia

NCT04302701 | Unknown

• 1 other identifier: Dichoptic-123
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amblyopia; Anisometropia

Outcome Measures

Primary Outcomes (1)

• Visual acuity at 10 weeks

  Change in amblyopic eye VA letter score from baseline to 10 weeks.

  10 weeks

Secondary Outcomes (5)

• Compliance to treatment

  10 weeks

• Number of patients developing misalignment

  10 weeks

• Regression of amblyopic eye visual acuity

  20 weeks

• Changes in visual acuity in the sound eye

  10 weeks

• Changes in near stereopsis

  10 weeks

Study Arms (2)

Dichoptic arm

EXPERIMENTAL

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

Patching

ACTIVE COMPARATOR

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

Interventions

Dichoptic treatment using virtual reality OTHER

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.

Dichoptic arm

Patching OTHER

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.

Patching

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.

  PMID: 14597512 BACKGROUND

• Hess RF, Thompson B, Baker DH. Binocular vision in amblyopia: structure, suppression and plasticity. Ophthalmic Physiol Opt. 2014 Mar;34(2):146-62. doi: 10.1111/opo.12123.

  PMID: 24588532 BACKGROUND

• Polat U, Ma-Naim T, Spierer A. Treatment of children with amblyopia by perceptual learning. Vision Res. 2009 Oct;49(21):2599-603. doi: 10.1016/j.visres.2009.07.008. Epub 2009 Jul 19.

  PMID: 19622368 BACKGROUND

• Manh VM, Holmes JM, Lazar EL, Kraker RT, Wallace DK, Kulp MT, Galvin JA, Shah BK, Davis PL; Pediatric Eye Disease Investigator Group. A Randomized Trial of a Binocular iPad Game Versus Part-Time Patching in Children Aged 13 to 16 Years With Amblyopia. Am J Ophthalmol. 2018 Feb;186:104-115. doi: 10.1016/j.ajo.2017.11.017. Epub 2017 Nov 28.

  PMID: 29196184 BACKGROUND

• Li SL, Reynaud A, Hess RF, Wang YZ, Jost RM, Morale SE, De La Cruz A, Dao L, Stager D Jr, Birch EE. Dichoptic movie viewing treats childhood amblyopia. J AAPOS. 2015 Oct;19(5):401-5. doi: 10.1016/j.jaapos.2015.08.003.

  PMID: 26486019 BACKGROUND

• Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.

  PMID: 28659140 BACKGROUND

Related Links

• The link to the software of the VR games used in this study

MeSH Terms

Conditions

Amblyopia; Anisometropia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: March 10, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after 3 years
• Access Criteria: The principal investigator will review requests for information.