Asymmetric Anisometropic
Conditions
Interventions
Experimental group:asymmetric anisometropic correction
Control group:full amblyopic-eye hyperopic correction
Sponsors
Beijing Radiant Children's Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 13 years; 2. Amblyopia associated with anisometropia previously spectacles treated at least 2 years and at least 1 year without improvement; 3. Anisometropic amblyopia at least one of the following criteria must be met: >=2.0 D difference between eyes in spherical equivalent; >=2.00 D difference between eyes in astigmatism in any meridian; 4. Visual acuity, measured in each eye with cycloplegia using the ATS single-surround HOTV protocol for subjects aged =20/25 (>=79 letters); Best corrected visual acuity in the amblyopic eye 20/25 to 20/200 (79 to 34 letters inclusive); Best corrected visual acuity in the fellow eye >=20/40 (>=69 letters); Inter-eye acuity difference >=3 logMAR lines (i.e., amblyopic eye acuity at least 3 lines by ATS-HOTV or at least 15 letters by E-ETDRS worse than the fellow eye acuity); 5. Requirements for required refractive error correction (based on a cycloplegic refraction within the last 6 months): Hypermetropia of 2.00 D or more by spherical equivalent; Astigmatism of 2.00 D or more; Anisometropia of more than 2.00 D spherical equivalent; 6. Spectacle correction must meet the follow the study-specied prescribing guidelines: Requirements for spectacle correction: Spherical equivalent must be >= 2.00 D correcting the anisometropia.
Exclusion criteria
Exclusion criteria: 1. Heterotropia in the primary gaze at distance, near fixation in the prescribed spectacles, or a documented history of strabismus; 2. Previous intraocular or refractive surgery; 3. Down syndrome or cerebral palsy; 4. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular vision; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual difference between eyes; | — |
Countries
China
Contacts
Public ContactZhisheng Li
Beijing Radiant Children's Hospital
Outcome results
None listed