An important clinical trial, sponsored by the National Eye Institute (NEI), a part of the National Institutes of Health (NIH), has provided doctors with improved prognostic indicators and treatment options for retinopathy of prematurity (ROP), a blinding disease that affects premature, low birthweight infants. ROP spurs the growth of abnormal blood vessels in the back of the eye. These vessels leak fluid and blood and scar the nerve tissue inside the eye, increasing the risk of retinal detachment and severe vision loss in infants.
Because it follows an unpredictable course, ROP presents doctors with difficult treatment decisions. In many infants the disease spontaneously regresses and spares vision. However, in some infants ROP progresses, resulting in serious visual impairment. Although appropriately timed laser therapy may stem its progression, many infants are still blinded by the disease. New information about the timing of laser treatment may improve visual outcomes for some of these high risk infants.
The Early Treatment for Retinopathy of Prematurity (ETROP) study results, published in the December issue of the Archives of Ophthalmology, demonstrated that premature infants, who are at the highest risk for developing vision loss from ROP, retained better vision when therapy is administered in an earlier stage of the disease. This treatment approach was found to be better than waiting until ROP has reached the traditional treatment threshold. Just as importantly, the study also established the value of an improved risk assessment model to more accurately identify those infants who are at the highest risk for developing severe vision loss from ROP.
"Premature, low birthweight infants face a host of medical complications with lifelong consequences. The results of this study allow us to improve treatment for ROP and, hopefully, the quality of life for children who most need sight-saving therapy," said Paul A. Sieving, M.D., Ph.D., director of the NEI.
Emory Eye Center's pediatric ophthalmologist Amy Hutchinson says, "As the regional referral center for ROP-related retinal detachments, we see many unfortunate children with vision loss from ROP despite appropriate treatment. We are hopeful that these new treatment recommendations will result in fewer retinal detachments, and better vision and quality of life for these high-risk babies." While on the faculty of South Carolina (Medical University of South Carolina, Charleston) Dr. Hutchinson participated in the ETROP study.
Each year ROP affects an estimated 14,000-16,000 premature, low birthweight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires treatment. Despite available treatment, about 400-600 infants with ROP still become legally blind each year. Researchers have identified birthweight of 2.75 pounds (1250 grams) or less as a major risk factor for developing ROP.
The previous standard treatment threshold for ROP hinged on the disease having progressed enough that the risk of retinal detachment approached 50 percent.