Anisometropic amblyopia
Conditions
Interventions
control group:None
experimental group:standardized near activities
Sponsors
Beijing Childrens Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1.Age between 3–7 years. Written informed consent obtained from a parent or legal guardian, child assent where appropriate. 2.Diagnosed of hyperopic anisometropic amblyopia Bilateral hyperopic refractive error with interocular difference in spherical equivalent >= +1.50D or interocular difference in cylindrical power >= 1.00D. Interocular difference in best-corrected visual acuity (BCVA) >= 2 lines on an age-appropriate visual acuity chart. BCVA in the amblyopic eye below the lower limit of normal for age and >= 0.2 (decimal); fellow eye BCVA within the normal range for age and >= 0.8 (decimal), with no structural ocular pathology. 3.Refractive correction and stability Able to wear full refractive correction as prescribed; if newly diagnosed, full correction will be prescribed before or at baseline. No history of intensive amblyopia treatment (e.g. atropine penalization, formal binocular training) in the last 3 months. 4.Cooperation Able, in the judgement of the investigator, to cooperate with the standardized near-vision task and OCT/OCTA examinations and to attend scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria 1.Ocular comorbidities Manifest strabismus with horizontal deviation > +-5 prism diopters at distance or near strabismus, nystagmus, significant ptosis, congenital cataract, corneal opacity, retinal or optic nerve disease, glaucoma, or any prior intraocular surgery or significant ocular trauma. 2.Systemic or neurological disease Known neurological or systemic conditions that may affect visual development or ocular blood flow, such as epilepsy, cerebral palsy, severe developmental delay, uncontrolled metabolic or cardiovascular disease. 3.Previous or concurrent amblyopia treatment Use of amblyopia treatments other than optimal refractive correction and standard patching within the previous 3 months, including atropine penalization, structured binocular or vision therapy, or use of other amblyopia training devices. Participation in another interventional clinical trial during the study period. 4.Medications affecting ocular circulation or accommodation Current use of systemic medications that may significantly influence ocular blood flow or accommodation, if judged clinically relevant by the investigator. 5.Imaging and cooperation issues Inability to obtain gradable OCT/OCTA images at screening despite repeated attempts. Behavioral or cognitive problems that preclude reliable performance of the near-vision task or visual acuity testing. 6.Other safety concerns Any other condition that, in the opinion of the investigator, would compromise participant safety, data quality, or adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best-corrected visual acuity;OCTA measurement index; | — |
Secondary
| Measure | Time frame |
|---|---|
| axial length;Fusion vision and stereoscopic vision; | — |
Countries
China
Contacts
Public ContactLi Li; Jiang JIngjing
Beijing Childrens Hospital,Capital Medical University
Outcome results
None listed