Clinical trial NCT06049459: Novel Amblyopia Treatment With Virtual Reality Games
Official title: Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Beta Sigma Kappa - College of Optometrists in Vision Development
name: VividVision
First posted: 2023-09-22
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Difference in Mean Change in Amblyopic Eye Visual Acuity
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Secondary outcomes:
measure: Difference in Change in Stereoacuity/Binocularity
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
measure: Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
measure: Difference in Mean Change in Attention
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
measure: Difference in Mean Change in reading eye movements
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
measure: Difference in Mean Change in visual-motor integration
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
measure: Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
timeFrame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References: