Novel Amblyopia Treatment With Virtual Reality Games
ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorMarjean Kulp
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Optical Correction
DeviceOptical correction (if needed)
Therapeutic Dichoptic Virtual Reality Games
DeviceVirtual Reality Game play for amblyopia treatment
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: Optical Correction aloneActive comparator 1 intervention
Group B: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical CorrectionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline to 16 weeks versus 16 weeks to 32 weeksSecondary outcomes
1
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.
Time frame
Baseline to 16 weeks versus 16 weeks to 32 weeks2
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).
Time frame
Baseline to 16 weeks versus 16 weeks to 32 weeks3
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.
Time frame
Baseline to 16 weeks versus 16 weeks to 32 weeks4
Difference in Mean Change in reading eye movements
Optical correction worn for testing with Readalyzer eye tracker.
Time frame
Baseline to 16 weeks versus 16 weeks to 32 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marjean Kulp
Lead sponsor
Ohio State University
Sponsor institution
Beta Sigma Kappa - College of Optometrists in Vision Development
Collaborator
VividVision
Collaborator
Source ClinicalTrials.gov