Amblyopia
Conditions
Interventions
Control Group :Standard patch
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) According to the expert consensus on amblyopia diagnosis (2011) of strabismus and pediatric ophthalmology group of Ophthalmology branch of Chinese Medical Association, the patients were diagnosed as amblyopia, that is, the best corrected vision of monocular or binocular caused by monocular strabismus, uncorrected anisometropia, high ametropia and form deprivation during visual development was lower than that of corresponding age, or the difference of binocular vision was 2 lines or more. The lower limit of normal visual acuity for children of different ages: the lower limit of normal visual acuity for children aged 3 to 5 years is 0.5, and the lower limit of normal visual acuity for children aged 6 and above is 0.7. 2) Custodian or subjects capable and willing to sign a consent form and to participate in the study. 3) Age of participants is between 5 to 12 years old (including 5 and 12 years old).The best corrected visual acuity (BCVA) in amblyopic eye > 20/200 (1.0 logMAR) and interocular BCVA difference >= 2 logMAR lines. 4) Capable cooperating with both the automatic and the manual tests. 5) Capable of sitting in front of a screen for 90 min. 6) Subjects diagnosed as having amblyopia and wear their optimal optical correction for at least 12 weeks or demonstrated stability of visual acuity (<0.1 logMAR change by the same testing method measured on 2 exams at least 4 weeks apart). 7) Heterotropia with a near deviation of <5PD (measured by SPCT) in habitual correction.
Exclusion criteria
Exclusion criteria: 1) Pre-existing concomitant pathology or conditions that would either interfere with the functioning of the device or with the reference standard examination or otherwise introduce confounding factors to the study outcomes such as parsleys of the extra ocular muscles or any other neurological deficiency that might affect eye movements, ptosis that cover the pupil. 2) Any amblyopia treatment (atropine, patching, Bangerter, vision therapy) except for glasses in the past 3 months. 3) The participants who were or had just completed visual training within the last 3 months. 4) Known skin reactions to patch or bandage adhesives. 5) The participants had other conditions that prevented the devices from tracking their eyes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (distance); | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (near);Stereopsis; | — |
Countries
China
Contacts
Public ContactLiu Rui
Eye and ENT Hospital of Fudan University
Outcome results
None listed