The Infant Aphakia Treatment Study (IATS) is a clinical study designed to determine which treatment for aphakia is better for infants between the ages of 4 weeks to 7 months who were born with a cataract in one eye. The treatments being studied are using a contact lens (CL) after surgery or surgically placing a plastic lens (intraocular lens IOL) in the baby's eye after removing the cataract.
114 babies were enrolled in the study between December 2004 and December 2008; 57 were in the CL treatment group and 57 were in the IOL treatment group. Vision in both eyes was tested at 1 year of age and again at 4 1/2 years of age. In 2010 the results of the vision testing at 1 year of age was published. There was no difference in the vision in the treated eyes when comparing CL to IOL treatment. However, in the first year there were more complications and additional intraocular surgeries in the IOL group, but these had been anticipated.
113 of the 114 children in the study were followed until they were 5 years old. The results of the entire study will be published in the Spring of 2014.
This clinical study has been closely monitored by the National Institutes of Health, Food and Drug Administration, and a board of specialists that ensured that the study was conducted safely. Surgeons and study team members are experts in caring for children with cataracts.