Emory Eye Center will be the lead center among other eye institutes across the country to determine what treatment for infants born with a cataract in one eye is the better to attain corrected vision once that cataract is removed: 1) using a contact lens or 2) surgically placing a plastic lens (intra-ocular lens [IOL]) in the baby's eye following removal of the cataract. The Infant Aphakia Treatment Study (IATS) will study infants from age four weeks to seven months.
This clinical study will be closely monitored by the National Institutes of Health (NIH), Food and Drug Administration, and a specially formed board of specialists. Surgeons and study team members are experts in this specialty field, board certified pediatric ophthalmologists. Thirteen sites will conduct the study, which is funded by the National Eye Institute, part of the NIH.
At Emory Eye Center, Scott Lambert, MD, will be principal investigator of the study. The study will begin signing up patients immediately and last five years. "This important study, the first of its kind, will help us determine the best way to focus the eyes of babies following cataract surgery, knowing this will allow these children to have the best chance of seeing normally out of these eyes," says Dr. Lambert.
Background When children are born with a cataract, the cloudy lens has to be removed in order to let light into the eye. Without the lens, something else has to focus the image onto the back of the eye for sight. One way to accomplish this is by using a contact lens. The parents of the affected baby learn how to insert the lens, clean it and patch the other eye (stronger) during waking hours so that the affected learns how to do the work of seeing. At this point, if a patch is not placed over the stronger eye, the eye with the lens will let the stronger eye do all the work. The vision in that "lazy eye" will then be poor, resulting in a condition known as amblyopia. An advantage of the contact lens is that focusing power can be changed throughout the child's life, as the eye changes.
The second way to replace the loss of the lens is to place a plastic lens inside the eye (an IOL) when the cataract is removed. By having an IOL, the baby will always have corrected vision. But the strength of the lens cannot be changed as the child grows and his or her needs change. At that time, vision correction will be accomplished by glasses. With this IOL treatment, too, patching is done during waking hours to prevent amblyopia from developing with the implanted eye.
Emory Eye Center is one of 13 sites across the country participating. Others include eye institutions in Boston, Miami, Charleston, S.C., Durham, N.C., Cleveland, Nashville, Tenn., Indianapolis, Minneapolis, Dallas. Houston,, Los Angeles and Portland, Ore.