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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00212134
Eligibility Criteria:
Inclusion Criteria:
* Visually significant unilateral congenital cataract (central opacity equal to or greater than 3 mm in size).
* Cataract surgery performed when the patient is 28 to 210 days of age and at least 41 post-conceptional weeks.
Exclusion Criteria:
* The cataract is known to be acquired from trauma or as a side-effect of a treatment administered postnatally such as radiation or medical therapy.
* A corneal diameter less than 9 mm measured in the horizontal meridian using calipers.
* An intraocular pressure of 25 mm Hg or greater in the affected eye measured with a Perkins tonometer, tonopen, or pneumatonometer.
* Persistent fetal vasculature (PFV) causing stretching of the ciliary processes or a tractional retinal detachment.
* Active uveitis or signs suggestive of a previous episode of uveitis such as posterior synechiae or keratic precipitates.
* The child is the product of a pre-term pregnancy (\<36 gestational weeks). Screening for prematurity will be based on the clinician's best assessment of gestational age. If a physician is uncertain regarding the gestational age, review of medical records or contact with the pediatrician and/or obstetrician should be used to confirm gestational age at delivery. Unless a clinician is uncertain as to whether a child was born at less than 36 weeks or not, confirmation of gestational age via medical record review may be delayed until after enrollment.
* Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity.
* Previous intraocular surgery.
* Optic nerve disease that may limit the visual potential of the eye such as optic nerve hypoplasia.
* The fellow eye has ocular disease that might reduce its visual potential.
* The child has a medical condition known to limit the ability to obtain visual acuity at 12 months or 4 years of age.
* Refusal by the Parent/Legal Guardian to sign an informed consent or to be randomized to one of the two treatment groups.
* Follow-up of the child is not feasible because the child would not be able to return for regular follow-up examinations and the outcome assessments (e.g. transportation difficulties, relocation, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
210 Days
Study:
NCT00212134
Study Brief:
Protocol Section:
NCT00212134