Table 1.

The Infant Aphakia Treatment Study

Randomized, multicenter (12 sites) clinical trial

114 infants with a unilateral congenital cataract randomized to cataract surgery with or without primary IOL implantation

Primary outcome: HOTV acuity at age 4.5 years tested by traveling examiner

Main inclusion criteria:

• Visually significant congenital cataract

• Age 1–6 months at time of cataract surgery

Main exclusion criteria:

• Persistent fetal vasculature with stretching of the ciliary processes

• Corneal diameter <9mm

• Medical condition that would interfere with visual acuity testing

• Premature birth (<36 gestational weeks)