Novel Amblyopia Treatment With Virtual Reality Games

Marjean Kulp

Status: Enrolling

Conditions: Amblyopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06049459

2023H0013

Details and patient eligibility

About

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

Enrollment: 8 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

8 participants in 2 patient groups

Optical Correction alone

Active Comparator group

Description:

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

Treatment:

Device: Optical Correction

Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

Experimental group

Description:

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

Treatment:

Device: Therapeutic Dichoptic Virtual Reality Games

Device: Optical Correction