Deprivation Amblyopia Clinical Trial
Official title:
Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 1, 2021 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 3 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - children after cataract surgery and healthy volunteers Exclusion Criteria: - presence of corneal opacity preventing detailed imaging - nystagmus - retinal disease, - persistent fetal vasculature - intraocular inflammation, - glaucoma - vitreoretinal surgery - premature birth - neurologic disease - systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease) |
| Country | Name | City | State |
|---|---|---|---|
| China | Eye Hospital of WMU | Hangzhou | Zhejiang |
| China | The affiliated Eye Hospital of Wenzhou Medical College | Wenzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Wenzhou Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Foveal retinal thickness | Foveal retinal thickness in microns | up to 36 months | |
| Primary | Area of foveal avascular zone | Area of foveal avascular zone in square microns | up to 36 months |