Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01844258
Eligibility Criteria:
Inclusion Criteria:
* Age between 1 month and 24 months
* Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
* Informed consent signed by a parent or legal guardian
Exclusion Criteria:
* Intraocular pressure \>21 mmHg
* Preterm birth (\<28 weeks)
* Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
* History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
* History of ocular trauma
* Microcornea
* Persistent hyperplastic primary vitreous
* Rubella
* Lowe syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
24 Months
Study:
NCT01844258
Study Brief:
Protocol Section:
NCT01844258