Actively Recruiting
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Led by Jaeb Center for Health Research · Updated on 2026-02-11
252
Participants Needed
58
Research Sites
17 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating dichoptic treatments for children aged 8 to 12 years with amblyopia, a condition affecting vision. This phase 3 randomized trial compares two types of virtual reality-based dichoptic therapy, Luminopia and Vivid Vision, against continued use of optical correction alone. The study aims to understand how these treatments impact vision improvement, specifically measuring changes in the amblyopic eyes visual acuity. Participants are randomly assigned to one of three groups Luminopia, involving watching dichoptic movies or shows using a headset for 1 hour daily six days a week Vivid Vision, playing dichoptic video games with a headset for about 25 minutes daily six days a week or continuing optical correction with glasses or contact lenses alone. Those initially assigned to optical correction alone who show limited improvement after 18 weeks may be re-randomized to receive one of the dichoptic therapies, with follow-up visits extending to 36 weeks. During the study, participants attend clinical assessments at 9 and 18 weeks after starting treatment, with additional visits at 27 and 36 weeks for some. Researchers measure visual acuity changes in the amblyopic eye using the logMAR scale and assess quality of life related to vision through a pediatric eye questionnaire. The study includes monitoring adherence to treatment, willingness to wear the headset and optical correction, and safety considerations throughout the 18 to 36-week participation period.
CONDITIONS
Brief Title
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and less than 13 years
- Visual acuity in the amblyopic eye from 20/40 to 20/200 inclusive
- Visual acuity in the fellow eye 20/25 or better
- Interocular difference of 3 or more logMAR lines (at least 15 letters)
- Amblyopia associated with strabismus, anisometropia, or both
- No more than 2 weeks of prior dichoptic treatment
- No cycloplegic eyedrops in the past 2 weeks
- Refractive correction required for specific levels of hypermetropia, myopia, astigmatism, or anisometropia
- Willingness to wear a headset and continue full-time spectacles or contact lenses if needed
- Interpupillary distance between 52mm and 72mm inclusive
- Investigator willing to prescribe necessary optical correction or dichoptic device
- Willing to accept random assignment to treatment groups for 19 weeks
- Parent understands the study and agrees to randomization
- Parent has phone access and agrees to contact
- No planned relocation outside study area within 36 weeks
You will not qualify if you...
- Heterotropia greater than 5 prism diopters at distance or near
- Prism correction greater than 8 diopters horizontal or 1 diopter vertical
- Current use of bifocal spectacles (unless discontinued 2 weeks prior)
- Myopia worse than -6.00 diopters spherical equivalent in either eye
- Eye conditions that may reduce visual acuity (except nystagmus if criteria met)
- Diplopia occurring more than once per week in the last week
- History of light-induced seizures
- Known simulator sickness
- Severe developmental delay interfering with treatment or evaluation
- Immediate family member of study personnel or Jaeb Center employees
Research Team
R
Raymond T Kraker, MSPH
B
Brooke P Fimbel
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