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<p>Follow-up results from a study of premature babies with a potentially blinding condition confirm that a freezing treatment applied to their eyes helps save their sight. The follow-up results also give researchers more information about how well the babies can see in the years after cryotherapy, the freezing treatment.</p><p>“We have good evidence that this treatment significantly reduces the number of infants who are blinded by retinopathy of prematurity,” said study chairman Earl A. Palmer, M.D., of OregonHealth Sciences University. “However, some patients may have an increased chance of having less-than-perfect vision after cryotherapy,”he added.</p><p>The latest findings are from a 5 1/2-year follow-up study of 291 infants who had cryotherapy for the condition, called retinopathy of prematurity (ROP), between January 1986 and January 1988. The infants were in the multi-center trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP), which was sponsored by the National EyeInstitute of the National Institutes of Health (NIH). Results of the follow-up study were published today in the April issue of the <em>Archives of Ophthalmology.</em></p><p>Current estimated figures for the United States show that more than 4,000 premature babies weighing 3.3 pounds or less develop eye damage or vision loss from ROP each year. If cryotherapy were not available,750 of the babies with the severe form of the disease would become legally blind each year, according to researchers’ predictions. With widespread use of cryotherapy, a smaller number of babies, 400, become blind from the disease annually, researchers estimate. The CRYO-ROP study involved higher-risk babies who weighed only 2.75 pounds or less at birth and had the severe form of the disease.</p><p>ROP occurs when, for unknown reasons, blood vessels that feed parts of the retina grow in excess and become misshapen after birth. The retina is the light-sensing nerve tissue that lines the back of the eye and is crucial for normal vision. The abnormal blood vessels cause bleeding and scarring that can make the retina peel away from the back of the eye.</p><p>Doctors performing cryotherapy use a cryoprobe—a hollow instrument filled with refrigerant—to stop the growth of the abnormal blood vessels. They touch spots on the surface of the eye with the probe, which reaches freezing temperatures. The surface of the eye is not permanently harmed, but the freezing temperature destroys the outer edge of the retina, stopping the growth of the abnormal blood vessels.</p><p>While some babies become blind from ROP, others achieve adequate or better vision if left untreated. In the years after CRYO-ROP, researchers evaluated the babies’ eyes that had been treated with cryotherapy and those that had not been treated to compare their vision and structure.</p><p>For the first several years, some of the children could not read a standard eye chart because they could not recognize letters or cooperate. Researchers used other methods to test the children’s vision until they were almost 6 years old.</p><p>For the 5 1/2-year follow-up study, researchers were able to test 75percent of the children using the standard eye chart. Vision of 20/40or better was considered to be in the normal range, and children with vision of 20/200, the legal definition of blindness, or worse were considered blind. The study shows that 62 percent of the infants’ eyes that were not treated with cryotherapy became blind, whereas 47percent of treated eyes became blind. This difference is statistically significant.</p><p>The findings also suggest that cryotherapy might be associated with less-than-perfect vision. Twenty percent of untreated eyes now have vision of 20/40 or better, while</p><p>13 percent of treated eyes have vision in that range. This difference is not statistically significant; in addition, 25 percent of the children could not be tested at the 5 1/2-year follow-up. At the next follow-up, researchers will include the children whom they previously could not test.</p><p>Because cryotherapy was shown to be so effective in preventing blindness, the National Eye Institute sent a nationwide clinical alert to physicians who care for premature infants when the study’s initial results became available in 1988. Since then, the treatment has become widely used.</p><p>“These results clearly favor cryotherapy for more severe cases of ROP, but we may want to be cautious about treating less severe ROP,” said Carl Kupfer, M.D., director of the National Eye Institute. “If the milder form of this disease is left untreated, most of the children will have healthy eyes and good vision later on. Cryotherapy might worsen their visual acuity without providing any benefit, “he added.</p><p>The researchers are preparing to perform another follow-up study of the children, who are now almost 10 years old. At that time, more of the children will have the skills required to take the standard eye chart test, and their visual systems will be more developed.Researchers will be able to investigate further the preliminary suggestion that cryotherapy, while effective in preventing blindness, might be associated with an increased chance of less-than-perfectvision.</p><p>The 5 1/2-year follow-up examination also showed that cryotherapy was associated with benefits other than blindness prevention in ROP.Children’s eyes that had been treated had fewer of the abnormalities, such as cataract, often seen in severe cases of the condition. Many doctors now use lasers instead of cryoprobes to stop ROP progression.Controversy exists over whether eyes treated with lasers are more likely to develop cataract than are eyes treated with cryoprobes.</p><p>In another NIH-supported study, researchers estimated that appropriate screening and treatment of ROP in premature infants would save society between $38 million and $65 million a year in special education, disability, and other costs, and in lost productivity.</p><p><em>The National Eye Institute is the Federal government’s lead agency for vision research, and supports more than 80 percent of such research conducted in the United States.</em></p><h3>Cryotherapy For Retinopathy of Prematurity (CRYO-ROP) Participants List</h3><dl><dt><p>Alabama</p></dt><dd><p>Frederick J. Elsas, M.D.<br>Alabama Ophthalmology Associates, P.C.<br>1000 - 19th Street South<br>Birmingham, Alabama 35205<br>Telephone: (205) 930-0700</p></dd><dt><p>California</p></dt><dd><p>Alan M. Roth, M.D.<br>Department of Ophthalmology<br>University of California at Davis Medical Center<br>1603 Alhambra Boulevard<br>Sacramento, California 95816<br>Telephone: (916) 734-6078</p></dd><dt><p>District of Columbia</p></dt><dd><p>William S. Gilbert, M.D.<br>Childrens Hospital National Medical Center<br>Retina Group of Washington<br>5454 Wisconsin Avenue, Suite 1540<br>Chevy Chase, Maryland 20815<br>Telephone: (301) 656-8100</p></dd><dd><p>David Plotsky, M.D.<br>650 Pennsylvania Avenue, S.E.<br>Suite 270<br>Washington, D.C. 20003<br>Telephone: (202) 544-1900</p></dd><dt><p>Florida</p></dt><dd><p>R. Michael Siatkowski, M.D.<br>Bascom Palmer Eye Institute<br>University of Miami School of Medicine<br>900 N.W. 17th Street<br>P.O. Box 016880<br>Miami, Florida 33136<br>Telephone: (305) 326-6019</p></dd><dt><p>Illinois</p></dt><dd><p>Marilyn T. Miller, M.D.<br>University of Illinois Eye and Ear Infirmary<br>1855 West Taylor Street, Room 1.44<br>Chicago, Illinois 60612<br>Telephone: (312) 996-7445</p></dd><dt><p>Indiana</p></dt><dd><p>Forrest D. Ellis, M.D.<br>Department of Ophthalmology<br>Indiana University School of Medicine<br>702 Rotary Circle<br>Indianapolis, Indiana 46202<br>Telephone: (317) 274-1214</p></dd><dt><p>Kentucky</p></dt><dd><p>Charles C. Barr, M.D.<br>Kentucky Lions Eye Research Institute<br>University of Louisville<br>301 East Muhammad Ali Boulevard<br>Louisville, Kentucky 40292<br>Telephone: (502) 852-5470</p></dd><dt><p>Louisiana</p></dt><dd><p>Robert A. Gordon, M.D.<br>Department of Ophthalmology<br>Tulane University<br>School of Medicine<br>1430 Tulane Avenue<br>New Orleans, Louisiana 70112<br>Telephone: (504) 588-5804</p></dd><dt><p>Maryland</p></dt><dd><p>Michael X. Repka, M.D.<br>Wilmer Ophthalmological Institute<br>The Johns Hopkins Medical Institutions<br>Wilmer Building, Room B1-35<br>600 North Wolfe Street<br>Baltimore, Maryland 21287-9009<br>Telephone: (410) 955-8314</p></dd><dt><p>Michigan</p></dt><dd><p>John D. Baker, M.D.<br>2355 Monroe Boulevard<br>Dearborn, Michigan 48124<br>Telephone: (313) 561-1777</p></dd><dd><p>Michael T. Trese, M.D.<br>Associated Retinal Consultants, P.C.<br>3535 West Thirteen Mile Road, Room 632<br>Royal Oak, Michigan 48073<br>Telephone: (313) 288-2280</p></dd><dt><p>Minnesota</p></dt><dd><p>C. Gail Summers, M.D.<br>Department of Ophthalmology<br>University of Minnesota<br>Phillips-Wangensteen Bldg., 9-240<br>Box 493, 420 Delaware Street, S.E.<br>Minneapolis, Minnesota 55455-0591<br>Telephone: (612) 625-4400</p></dd><dt><p>New York</p></dt><dd><p>Dale L. Phelps, M.D.<br>Box 651, Neonatology<br>University of Rochester SOM<br>601 Elmwood Avenue<br>Rochester, New York 14642<br>Telephone: (716) 275-5884</p></dd><dt><p>North Carolina</p></dt><dd><p>Edward G. Buckley, M.D.<br>Duke University Eye Center<br>Box 3802<br>Durham, North Carolina 27710<br>Telephone: (919) 684-6084</p></dd><dt><p>Ohio</p></dt><dd><p>Miles J. Burke, M.D.<br>Department of Ophthalmology<br>Childrens Hospital Medical Center<br>Pavilion 2-80<br>3333 Burnet Avenue<br>Cincinnati, Ohio 45229-3039<br>Telephone: (513) 559-4751</p></dd><dd><p>Gary L. Rogers, M.D.<br>Don L. Bremer, M.D.<br>Columbus Childrens Hospital<br>(Office Address) 555 South 18th Street<br>Columbus, Ohio 43205<br>Telephone: (614) 224-6222</p></dd><dt><p>Oregon</p></dt><dd><p>Earl A. Palmer, M.D.<br>Oregon Health Sciences University<br>Casey Eye Institute<br>3375 S.W. Terwilliger Boulevard<br>Portland, Oregon 97201-4197<br>Telephone: (503) 494-5945</p></dd><dt><p>Pennsylvania</p></dt><dd><p>Graham E. Quinn, M.D.<br>David B. Schaffer, M.D.<br>Children’s Hospital of Philadelphia<br>Division of Pediatric Ophthalmology<br>One Children’s Center<br>Philadelphia, Pennsylvania 19104<br>Telephone: (215) 590-2791</p></dd><dd><p>Kenneth P. Cheng, M.D.<br>Pediatric Ophthalmology & Strabismus<br>3518 Fifth Avenue<br>Pittsburgh, Pennsylvania 15213-3387<br>Telephone: (412) 682-6300</p></dd><dt><p>South Carolina</p></dt><dd><p>Richard A. Saunders, M.D.<br>Storm Eye Institute<br>Medical University of South Carolina<br>171 Ashley Avenue<br>Charleston, South Carolina 29425-2236<br>Telephone: (803) 792-2761</p></dd><dt><p>Tennessee</p></dt><dd><p>Stephen S. Feman, M.D.<br>Department of Ophthalmology<br>Vanderbilt University Medical Center<br>8000 Medical Center East<br>Nashville, Tennessee 37232-8808<br>Telephone: (615) 936-2020</p></dd><dt><p>Texas</p></dt><dd><p>Rand Spencer, M.D.<br>7150 Greenville Ave., Suite 400<br>Dallas, Texas 75231<br>Telephone: (214) 821-4540</p></dd><dd><p>Wichard A. Van Heuven, M.D.<br>Department of Ophthalmology<br>University of Texas Health Science Center<br>7703 Floyd Curl Drive<br>San Antonio, Texas 78284-6230<br>Telephone: (210) 567-8400</p></dd><dt><p>Utah</p></dt><dd><p>Robert O. Hoffman, M.D.<br>Department of Ophthalmology<br>John Moran Eye Center<br>50 North Medical Drive<br>Salt Lake City, Utah 84132<br>Telephone: (801) 581-4955</p></dd></dl><h3>Resource Centers</h3><dl><dt><p>Chairman’s Office</p></dt><dd><p>Earl A. Palmer, M.D.<br>Casey Eye Institute<br>3375 S.W. Terwilliger Boulevard<br>Portland, Oregon 97201-4197<br>Telephone: (503) 494-5945</p></dd><dt><p>Coordinating Center</p></dt><dd><p>Robert J. Hardy, Ph.D.<br>School of Public Health<br>University of Texas Health Science Center<br>Coordinating Center for Clinical Trials<br>1200 Herman Pressler Street, Suite 801<br>Houston, Texas 77030<br>Telephone: (713) 792-4495</p></dd><dt><p>Ocular Pathology Center</p></dt><dd><p>David J. Wilson, M.D.<br>Casey Eye Institute<br>3375 S.W. Terwilliger Boulevard<br>Portland, Oregon 97201-4197<br>Telephone: (503) 494-7881</p></dd><dt><p>Vision Center</p></dt><dd><p>Velma Dobson, Ph.D.<br>University of Arizona, SOM<br>Dept. of Ophthalmology<br>1801 North Campbell<br>Tucson, AZ 85719-3758<br>Telephone: (520) 321-3677</p></dd></dl><p># #</p><h3>Citations</h3><ul><li>Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Snellen Visual Acuity and Structural Outcome 5 1/2 Years After Randomization. Cryotherapy for Retinopathy of Prematurity Cooperative Group. <em>Arch Ophthalmol</em>. 1996 Apr. <a href="https://pubmed.ncbi.nlm.nih.gov/8602778/">PubMed</a></li></ul>
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