Figure 1. CONSORT Diagram for the Infant Aphakia Treatment Study.

^aOne patient was found to have stretching of the ciliary processes intraoperatively after randomization to the intraocular lens group. The investigator decided that an intraocular lens could not be safely implanted, and the patient’s aphakia was treated with a contact lens.

^bOne patient had developmental delay and could not complete the HOTV acuity test at age 4.5 years.

^cTwo patients had a secondary intraocular lens implanted at age 1.3 and 3.0 years after randomization. A third patient had a secondary intraocular lens implanted at 4.7 years after randomization and after the primary end point was assessed but before the last clinical examination at age 5 years.