Novel Amblyopia Treatment With Virtual Reality Games

NCT06049459 | Recruiting FDA Device

• 1 other identifier: 2023H0013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Amblyopia

Outcome Measures

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

  Baseline to 16 weeks versus 16 weeks to 32 weeks

Secondary Outcomes (6)

• Difference in Change in Stereoacuity/Binocularity

  Baseline to 16 weeks versus 16 weeks to 32 weeks

• Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity

  Baseline to 16 weeks versus 16 weeks to 32 weeks

• Difference in Mean Change in Attention

  Baseline to 16 weeks versus 16 weeks to 32 weeks

• Difference in Mean Change in reading eye movements

  Baseline to 16 weeks versus 16 weeks to 32 weeks

• Difference in Mean Change in visual-motor integration

  Baseline to 16 weeks versus 16 weeks to 32 weeks

Study Arms (2)

Optical Correction alone

ACTIVE COMPARATOR

Optical correction alone (16 weeks) (Each participant will complete both study conditions.)

Device: Optical Correction

Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

EXPERIMENTAL

Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)

Device: Optical Correction; Device: Therapeutic Dichoptic Virtual Reality Games

Interventions

Optical Correction DEVICE

Optical correction (if needed)

Optical Correction alone; Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

Therapeutic Dichoptic Virtual Reality Games DEVICE

Virtual Reality Game play for amblyopia treatment

Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marjean Kulp: lead
• Beta Sigma Kappa - College of Optometrists in Vision Development: collaborator
• VividVision: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Amblyopia

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

Central Study Contacts

Marjean T Kulp, OD, MS

CONTACT

614-688-3336; kulp.6@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be masked to past performance and adherence.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: March 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)