Novel Amblyopia Treatment With Virtual Reality Games

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049459
• Other study ID #: 2023H0013
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Marjean T Kulp, OD, MS
• Phone: 614-688-3336
• Email: kulp.6[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Marjean Kulp	Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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