Health Condition 1: H530- Amblyopia ex anopsia
Conditions
Interventions
Intervention1: Bynocs DAT (Dichoptic Amblyopia Training) Game: Bynocs Dichoptic Amblyopia Training Game is a computer-based game with ability to adjust contrast of the stimulus of each eye, spatial fr
Sponsors
Kanohi Eye Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 4 to 12 years boys and girls. 2. Amblyopia associated with anisometropia previously treated or untreated a Criteria for anisometropia At least one of the following criteria must be met Greater than or equal to 1.00 D difference between eyes in spherical equivalent. Greater than or equal to 1.50 D difference in astigmatism between corresponding meridians in the two eyes. b Criteria for combined-mechanism amblyopia Both of the following criteria must be met. Greater than or equal to 1.00 D difference between eyes in spherical equivalent OR Greater than or equal to 1.50 D difference in astigmatism between corresponding meridians in the two eyes. 3. Amblyopia associated with anisometropia, meeting at least one of the following conditions. Newly diagnosed amblyopia or If there had been prior amblyopia treatment, it must have been discontinued with no treatment administered for not a minimum of 8 weeks prior to the Screening Visit. 4. Must have refractive error correction based on a cycloplegic refraction completed within the last 7 months if any of the following are true. Hypermetropia of 2.50 D or more by spherical equivalent SE. Myopia of amblyopic eye of 0.50D or more SE. Astigmatism of 1.00D or more. Anisometropia of more than 0.50D SE. 5. VA, measured in each eye without cycloplegia in current spectacle correction if applicable within 7 days prior to randomization using the ETDRS VA protocol. 6. Heterotropia with a near deviation of less than 5 measured by SPCT in habitual correction. 7. Participant is able to play Bynocs DAT game. 8 Participant and families eligible for clinic visits over duration of study. 9 Participant in general good health and able, as per investigator decision. 10 Participant has access to internet at home which is able to support the Bynocs DAT game. 11 Signed and dated informed consent form or assent form if applicable. 12 Parent and participant understand and are willing to comply with study procedures.
Exclusion criteria
Exclusion criteria: A Participant is excluded for any of the following reasons: 1. Myopia greater than -6.00 D. spherical equivalent in either eye. 2. Known skin reactions to patch or bandage adhesives. 3. Any other condition which could be a potential cause for reduced BCVA according to the investigator. 4. 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. 5. History of low adherence with amblyopia treatment as assessed informally by the investigator. 6. Participant that do not wear their spectacles. (as assessed by investigator) 7. History of light-induced seizures. 8. Wearing RGP (Rigid Gas Permeable) contact lenses. 9. Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer). 10. Previous intraocular or refractive surgery. 11. Any condition that prevents the Participant from completing a continues 40-60 min. of treatment per day while seating in front of a nearby screen. 12. Heterophoria with a total near deviation of Greater than or equal to 4Î? (measured by Simultaneous Prism Cover Test (SPCT)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bynocs DAT game treatment to improve the visual acuity of amblyopia eye when compared to baseline as compared to standard of care arm.Timepoint: To investigate primary outcome results at 6, 12, 18 and or 24 weeks of BYNOCS DAT game treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether Bynocs DAT treatment leads to improvement in stereopsis and contrast sensitivity and reduce interocular suppression when compared to baseline and as compared to standard of care arm.Timepoint: To assess the secondary outcome results at 16 weeks. | — |
Countries
India
Contacts
Public ContactMd Oliullah Abdal
LV Prasad Eye Institute
Outcome results
None listed