Study seeks to answer questions about IOL use in pediatric cataract patients

KIAWAH ISLAND, S.C. — Although currently an off-label use, IOLs may be an alternative for management of congenital cataract in infants, according to a physician here at Kiawah Eye 2009.

M. Edward Wilson Jr.

The Infant Aphakia Treatment Study, sponsored by the National Eye Institute, will look at the use of an AcrySof SN60 IOL (Alcon), which is being used under an investigational device exemption by the U.S. Food and Drug Administration. M. Edward Wilson Jr., MD, a principal investigator in the study, said 114 infants have been enrolled into the multicenter, controlled, randomized trial that will compare IOLs and glasses with aphakia and contact lenses in the first 6 months of life.

The trial will look at visual acuity at 12 months as a primary outcome and will monitor adverse events. In secondary outcomes, Dr. Wilson said, the trial will evaluate parental stress associated with managing the child's disorder, as well as adherence to the discretionary patching protocol in the study.

IOL implantation will be offered to aphakic patients at the end of the study, he said.

Dr. Wilson said that the Pediatric Clinical Committee of the American Society of Cataract and Refractive Surgery, a group he chairs, recently petitioned the FDA to roll back the indicated age range for IOLs. The move is not without precedent: The FDA previously lowered the age range for IOLs from 60 years to 18 years after several published studies showed the safety and efficacy of IOL use in younger patients.

Kiawah Eye 2010 will be held May 13-15, 2010 at the Kiawah Island Golf Resort in South Carolina. Learn more at KiawahEye.com.