Novel Amblyopia Treatment With Virtual Reality Games

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

Official Title
-----------------
Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: Optical Correction
* Device: Therapeutic Dichoptic Virtual Reality Games


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ages 5 to 17 years of age Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd Age normal VA in the nonamblyopic eye Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart) Interocular difference of ≥ 3 lines No amblyopia treatment in the past 2 weeks An interpupillary distance of 52-72 mm (inclusive) Exclusion Criteria: Myopia greater than -6.00 diopters (D) spherical equivalent in either eye. Previous intraocular or refractive surgery. Previous dichoptic treatment > 2 weeks in duration Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met). Diplopia more than once per week over the last week prior to enrollment by parental report. Down syndrome or cerebral palsy. Light-induced seizures Known simulator sickness Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optical Correction alone<br>Optical correction alone (16 weeks) (Each participant will complete both study conditions.) | Device: Optical Correction<br>* Optical correction (if needed)<br>|
| Experimental: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction<br>Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) | Device: Optical Correction<br>* Optical correction (if needed)<br>Device: Therapeutic Dichoptic Virtual Reality Games<br>* Virtual Reality Game play for amblyopia treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Mean Change in Amblyopic Eye Visual Acuity | Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older | Baseline to 16 weeks versus 16 weeks to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Change in Stereoacuity/Binocularity | Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score. | Baseline to 16 weeks versus 16 weeks to 32 weeks | 
| Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity | Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units). | Baseline to 16 weeks versus 16 weeks to 32 weeks | 
| Difference in Mean Change in Attention | Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing. | Baseline to 16 weeks versus 16 weeks to 32 weeks | 
| Difference in Mean Change in reading eye movements | Optical correction worn for testing with Readalyzer eye tracker. | Baseline to 16 weeks versus 16 weeks to 32 weeks | 
| Difference in Mean Change in visual-motor integration | Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15 | Baseline to 16 weeks versus 16 weeks to 32 weeks | 
| Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ) | Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best) | Baseline to 16 weeks versus 16 weeks to 32 weeks |