Novel Amblyopia Treatment With Virtual Reality Games

Official title

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

Overview

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

Interventions

• Device Optical Correction
  Optical correction (if needed)
• Device Therapeutic Dichoptic Virtual Reality Games
  Virtual Reality Game play for amblyopia treatment

Primary outcome measures

• Difference in Mean Change in Amblyopic Eye Visual Acuity [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]

Secondary outcome measures (6)

• Difference in Change in Stereoacuity/Binocularity [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]
• Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]
• Difference in Mean Change in Attention [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]
• Difference in Mean Change in reading eye movements [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]
• Difference in Mean Change in visual-motor integration [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]
• Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ) [Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The Ohio State University College of Optometry — Columbus

Identifiers

NCT: NCT06049459 · 2023H0013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗