Table 1.

IATS Inclusion/Exclusion Criteria

Inclusion Criteria Visually significant congenital cataract (≥ 3 mm central opacity) in one eye. Age 28 days to less than 7 months (<210 days) at the time of cataract surgery. At least 41 post-conceptional weeks at the time of cataract surgery. Written informed consent provided by parent or legal guardian agreeing that the patient could be randomized in the operating room if the exam under anesthesia confirmed that the patient was eligible for the study.

Exclusion Criteria The cataract was known to be acquired from trauma or as a side effect of a treatment administered postnatally. Corneal diameter < 9 mm. Intraocular pressure 25 mm Hg or greater. Persistent fetal vasculature (PFV) causing stretching of the ciliary processes or a tractional detachment of the retina. Active uveitis or signs suggestive of a previous episode of uveitis. The child was the product of a pre-term pregnancy (<36 gestational weeks). Retinal disease that may limit the visual potential of the eye. Previous intraocular surgery. Optic nerve disease that may limit the visual potential of the eye. The fellow eye had ocular disease that might reduce its visual potential. The child had a medical condition that might impair visual acuity testing at 12 months or 4 1/2 years of age. The child was not able to return to an IATS clinical center for regular follow-up examinations.