Anisometropic amblyopia Strabismic amblyopia Refractive amblyopia
Conditions
Interventions
Amblyopia treatment using virtual reality
Sponsors
Hori Yuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pediatric patients aged 3-10 years 2) Patients with anisometropic amblyopia, strabismic amblyopia, or refractive amblyopia 3) Best-corrected visual acuity of the amblyopic eye at screening is 0.5 or less in decimal visual acuity 4) Best-corrected visual acuity of the fellow eye at screening is 0.6 or greater in decimal visual acuity
Exclusion criteria
Exclusion criteria: 1) Cases where consent cannot be obtained from a legally authorized representative 2) When informed assent is possible but consent cannot be obtained from study subjects 3) History of intraocular surgery or refractive surgery 4) History of photosensitive epilepsy 5) Pediatric patients unable to comply with the study protocol (due to psychological, familial, social, geographic, or other reasons) 6) Patients who are determined to be unable to coordinate their eyes and hands(When it is determined that the candidate is unable to perform eye-hand coordination due to physical or mental reasons, or based on the results of testing the examination equipment.) 7) Other pediatric patients judged by the principal investigator or co-investigators to be unsuitable as study subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in best-corrected visual acuity of the amblyopic eye from baseline to 12 weeks in the VR-app group is non-inferior to that in the fellow-eye patching group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparisons of best-corrected visual acuity of the amblyopic eye at weeks Baseline, 4, 8, 12, 16, 20, and 24, between and within the fellow-eye patching group and the VR-app group. 2) Comparisons of stereopsis of the amblyopic eye at weeks Baseline, 4, 8, 12, 16, 20, and 24, between and within the fellow-eye patching group and the VR-app group. 3) Comparison of stereopsis measured by the pediatric amblyopia treatment VR app with stereopsis measured during clinical visits at weeks Baseline, 4, 8, 12, 16, 20, and 24 within the VR-app group. 4) Comparisons of the ratio of total wearing time to target wearing time at weeks 4, 8, 12, 16, 20, and 24, between and within the fellow-eye patching group and the VR-app group. 5) Comparisons of the angle of strabismus of the amblyopic eye at weeks Baseline, 4, 8, 12, 16, 20, and 24, between and within the fellow-eye patching group and the VR-app group. 6) Assessment of the association between VR-game playing conditions (e.g., game type, date/time of play, duration of play, achievement status regarding game challenges/levels) and best-corrected visual acuity, stereopsis, ratio of total wearing time to target wearing time, and angle of strabismus of the amblyopic eye in the VR-app group. 7) Investigation of device malfunctions. 8) Adverse events. 9) Usability assessment (VR-app group only). | — |
Contacts
Public ContactSaiko Matsumura
Toho University Omori Medical Center
Outcome results
None listed