Strategy to Help Doctors Determine When to Treat Retinopathy of Prematurity

Surgery or Careful Monitoring of Infants Depends on Disease Characteristics

Apr 29, 2010

NEW YORK

Scientists have shown that through eye examinations, doctors can identify infants who are most likely to benefit from early treatment for a potentially blinding eye condition called retinopathy of prematurity (ROP), resulting in better vision for many children.

These long-term results of the Early Treatment for Retinopathy of Prematurity (ETROP) study confirm that the visual benefit of early treatment for selected infants continues through six years of age. The research is published in the April 12 online issue of Archives of Ophthalmology and was supported by the National Eye Institute (NEI), part of the National Institutes of Health. The Edward S. Harkness Eye Institute at NewYork-Presbyterian Hospital/Columbia University Medical Center and NewYork-Presbyterian/Morgan Stanley Children's Hospital were among the 26 participating study sites.

"We showed that early treatment for high-risk premature babies can improve their vision. This research promises to transform the way babies with ROP are treated," says Dr. John Flynn, study principal investigator and the Anne S. Cohen Professor of Clinical Pediatric Ophthalmology at Columbia University College of Physicians and Surgeons and an ophthalmologist at NewYork-Presbyterian/Morgan Stanley Children's Hospital and professor of medicine at Weill Cornell Medical College.

"We showed there isn't a single treatment strategy that works for all infants with ROP, but rather that doctors need to determine whether the baby has a mild or severe form of the disease before proceeding with retinal surgery," adds study co-author Dr. Michael Chiang, associate professor of ophthalmology at Columbia University College of Physicians and Surgeons and an ophthalmologist at NewYork-Presbyterian Hospital/Columbia University Medical Center. "This can be determined with a simple bedside exam using an ophthalmoscope to look at blood vessels in the retina."

An estimated 15,000 premature infants born each year in the United States are affected by some degree of ROP. At-risk infants generally are born before 31 weeks of the mother's pregnancy and weigh 2.75 pounds or less.

This disease, which usually develops in both eyes, is one of the most common causes of vision loss in children. About 90 percent of infants with ROP have a mild form that does not require treatment, but those who have a more severe form can develop lifelong visual impairment, and possibly blindness.

During pregnancy, the blood vessels of the eye gradually grow to supply oxygen and essential nutrients to the light-sensitive retina. If a baby is born prematurely, growth of the blood vessels may stop before they reach the edge of the retina. In these newborns, abnormal, fragile blood vessels and retinal tissue may develop at the edges of the normal tissue. The abnormal vessels can bleed, resulting in scars that pull on the retina. The main cause of visual impairment and blindness in ROP is retinal detachment. Laser therapy or cryotherapy, using freezing temperatures, are the most effective treatments to slow or stop the growth of abnormal blood vessels.

Previously, doctors treated infants with ROP when they estimated their risk for retinal detachment to be 50 percent, a strategy developed through the NEI-supported Cryotherapy for Retinopathy of Prematurity study. Although this was a major finding, many infants still went on to develop severe eye disease. Therefore, the first phase of the ETROP study aimed to discover if doctors could identify infants at a higher risk for progression of the disease and intervene early to improve their vision.

In 2003, the ETROP study found that early treatment — upon diagnosis as higher risk for severe ROP — improved the vision and retinal health of certain infants after nine months. These infants had dilated or twisted blood vessels in the retina and substantial growth of new blood vessels, classified as Type 1 disease. Eyes with Type 2 ROP, or a more moderate amount of new blood vessel growth, did not benefit from early treatment. Doctors could predict which infants were more likely to benefit from early treatment by identifying certain eye characteristics, such as the appearance and location of the blood vessels.

The current study followed the same 370 children through six years of age, when researchers checked their vision and examined the development of their eyes. The nine-month study recommendations were confirmed through six years. Type 1 eyes benefitted from early treatment, and Type 2 eyes had similar results with either early treatment or treatment at the standard time. Seventy-five percent of the early-treated Type 1 eyes were spared legal blindness, compared with 67 percent of Type 1 eyes that received treatment at the standard time. Of the Type 2 eyes that were carefully monitored for disease progression through the standard protocol, more than half improved without treatment.

The study's chair is Dr. William V. Good of Smith-Kettlewell Eye Research Institute in San Francisco.

Weill Cornell Medical College

Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston, making Weill Cornell one of only two medical colleges in the country affiliated with two U.S.News & World Report Honor Roll hospitals. For more information, visit Weill Cornell Medical College.

NewYork-Presbyterian Hospital

NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,353 beds. The Hospital has more than 1 million inpatient and outpatient visits in a year, including more than 220,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.

Columbia University Medical Center

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the most comprehensive medical research enterprise in New York City and State and one of the largest in the United States. Columbia University Medical Center is affiliated with NewYork-Presbyterian Hospital, the nation's largest not-for-profit hospital provider. For more information, please visit www.cumc.columbia.edu.

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