Dichoptic Treatment for Lazy Eye
(ATS24 Trial)
Trial Summary
What is the purpose of this trial?
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does require stopping cycloplegic eyedrops (like atropine) two weeks before joining the study.
What data supports the effectiveness of the treatment Luminopia One for lazy eye?
Research shows that dichoptic treatments like Luminopia One, which involve presenting different images to each eye, can improve visual acuity (sharpness of vision) and encourage better adherence in children with amblyopia (lazy eye). These treatments are more engaging for children, potentially leading to better compliance and outcomes compared to traditional methods.12345
Is dichoptic treatment for lazy eye safe for humans?
How is the dichoptic treatment for lazy eye different from other treatments?
The dichoptic treatment for lazy eye, like Luminopia and Vivid Vision, is unique because it uses therapeutic modifications to streaming content or movies to balance visual input from each eye, making it more engaging and potentially improving adherence compared to traditional methods like eye patches or blurring drops.238910
Research Team
Marjean T Kulp, OD
Principal Investigator
Ohio State University
Benajmin G Jastrzembski, MD
Principal Investigator
University of California, Davis
Eligibility Criteria
This trial is for children aged 8 to less than 13 with lazy eye (amblyopia) ranging from mild to severe (20/40 to 20/200 vision). They must have a significant difference in vision between eyes and may have associated conditions like strabismus or anisometropia. Kids with very slight eye alignment issues are included, but those with more serious unrelated health problems cannot participate.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Luminopia dichoptic treatment, Vivid Vision dichoptic treatment, or continued optical correction alone, with clinical assessments at 9- and 18-weeks post-randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Extension
Participants initially receiving optical correction alone with an IOD of 1 logMAR line or more may opt into further dichoptic therapy and are followed with visits at 27- and 36-weeks post-randomization
Treatment Details
Interventions
- Luminopia (Behavioural Intervention)
- Vivid Vision (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jaeb Center for Health Research
Lead Sponsor
Dr. Roy W. Beck
Jaeb Center for Health Research
Chief Medical Officer since 2022
MD, PhD
Adam Glassman
Jaeb Center for Health Research
Chief Executive Officer since 2023
PhD in Biostatistics
Pediatric Eye Disease Investigator Group
Collaborator
National Eye Institute (NEI)
Collaborator
Dr. Michael F. Chiang
National Eye Institute (NEI)
Chief Executive Officer since 2020
MD from Harvard Medical School
Dr. Richard Lee
National Eye Institute (NEI)
Chief Medical Officer since 2021
MD, PhD from Harvard Medical School