Novel Amblyopia Treatment With Virtual Reality Games

Launched by MARJEAN KULP · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for amblyopia, often referred to as "lazy eye," in children aged 5 to 17. The researchers want to see if playing special virtual reality games for about 25 minutes a day, six days a week, can help improve vision in the weaker eye more effectively than just wearing glasses alone. The trial will compare two treatment periods: one where participants continue to wear their glasses for 16 weeks and another where they play the virtual reality games along with wearing their glasses for the same duration.

To participate, children must have moderate to severe amblyopia and have been wearing glasses for at least 16 weeks. They should also have a significant difference in vision between their two eyes. Not everyone will qualify; for instance, children with certain eye conditions or those who have had previous eye surgeries may be excluded. Participants will be closely monitored and will receive care during the trial to ensure their safety and well-being. This study is currently looking for participants, so if your child meets the eligibility criteria, this could be a great opportunity to explore a potentially helpful new treatment!

Gender

ALL

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.