Organizations Call for Expanding the Number of Babies Evaluated; Meeting the Need with Digital Screening
PLEASANTON, CA, March 21, 2006 – Doctors throughout the United States are already struggling to meet the demands of screening premature infants for a potentially blinding eye disease called retinopathy of prematurely (ROP). Now, new guidelines issued by several leading medical associations are likely to strain these healthcare resources even further.
The American Academy of Pediatrics (AAP) and American Academy of Ophthalmology (AAO), together with the American Association for Pediatric Ophthalmology and Strabismus, have just released updated recommendations that significantly increase the number of babies who should be screened for ROP. The guidelines now advise screening all infants born prior to 32 weeks or weighing less than 1500 grams (about 3.5 pounds). This is a significant change from the last guidelines, issued in 2001, which included the same weight criterion but recommended screening babies born at less than 28 weeks.
Based on estimates of premature births from the March of Dimes and other organizations, the new guidelines would require screening more than 50,000 babies annually.
The expanded screening criteria come at a time when the number of ophthalmologists who specialize in ROP has been steadily declining. As a result, not all neonatal intensive care units (NICUs) have an ROP specialist on staff. Yet, the AAP/AAO guidelines specifically state that evaluation for ROP should be performed by a physician with "sufficient knowledge and experience" to accurately identify the changes in the retina that are indicative of ROP.
With fewer and fewer specialists available to treat a growing number of at-risk babies, some experts see a looming crisis in ROP screening.
“The new guidelines, which are an important step in saving babies’ vision, could further sharpen the disparity between the pool of qualified physician screeners and the population of infants to be screened,” said Steven Schwartz, MD, chief of the Retina Division at the Jules Stein Eye Institute at UCLA Medical Center. “Any technology that can bring screening expertise to an otherwise underserved population might dramatically decrease preventable vision loss.”
A Telemedicine Solution
One solution to the screening crisis can be found in remote screening, whereby babies are examined in one location and their eye scans are evaluated by a physician at another location. While such approaches are already widely used in other areas of medicine, there has until recently been no enabling technology for remote ROP screening.
The RetCam™, the first high-quality, digital imaging system designed specifically for children’s eyes, has changed that. This technology now allows screening examinations to be performed without having an experienced physician at the baby’s bedside.
In the remote screening model, examinations are performed by neonatologists, NICU nurses or other medical or allied health personnel at the hospital where the baby is located. These images are then transmitted to an offsite ophthalmologist with expertise in ROP who can evaluate the condition of the eye, determine which babies are doing well, which need to be followed up again, and which need to be referred immediately for more complete evaluation.
“Remote screening has the potential to become a major factor in ensuring adequate evaluation for ROP. Since there is no longer a need to delay exams until a doctor can physically examine the baby, screening can be performed as often and as timely as the baby’s condition requires,” said Darius Moshfeghi, MD, head of retinal surgery at Lucile Packard Children’s Hospital at Stanford University Medical Center. “I believe we are going to see more and more such efforts take shape in the near future.”
Sharing the Responsibility for Screening
The new guidelines also stress the importance of performing “carefully timed” examinations, especially in light of recent research showing that early treatment reduces vision loss. To this end, the associations highlight the need for coordination between neonatologists and ophthalmologists to establish and adhere to screening protocols.
"Everyone caring for these babies – ophthalmologists, pediatricians, neonatologists, neonatal nurses, and parents – needs to be aware of the importance of timely ROP examinations for these high-risk infants," said Michael Chiang, MD, assistant professor of ophthalmology and biomedical informatics at Columbia University College of Physicians and Surgeons in New York. "We know that early treatment can prevent visual loss, and we owe it to each baby to do whatever is necessary to preserve as much of his or her sight as possible."
About ROP
ROP is a serious eye disorder, caused by premature birth that can result in significant visual loss or even blindness if the condition is not diagnosed and treated quickly. The National Eye Institute of the NIH estimates that each year approximately 1500 infants in the United States develop some manifestation of retinopathy of prematurity (ROP). Of these, 400-600 will become legally blind, making ROP one of the leading causes of childhood blindness.
About Clarity Medical Systems (www.claritymsi.com)
Clarity Medical Systems is a privately held medical technology company that develops, manufactures and markets integrated optical systems and services to enhance the clinician's ability to diagnose, evaluate and treat eye disorders. The company’s patented devices combine innovative optical, electronic and information technologies that change the very nature of how eye healthcare is delivered. Clarity’s flagship product is the RetCam II Digital Imaging system, which has revolutionized the standard of ophthalmologic evaluation in infants and children. The RetCam is being used by leading medical centers worldwide, including the foremost U.S. children’s hospitals. Clarity is also developing a full line of advanced products and services for adult eye healthcare. The company expects to introduce the first of these offerings in 2006.