February 12, 1988
Clinical Alert to Pediatric Ophthalmologists, Retinal Specialists, Neonatologists, and Directors of Neonatal Intensive Care Units
This letter is to inform you of significant new findings from the clinicaltrial, Cryotherapy for Retinopathy of Prematurity (CRYO-ROP). This study issponsored by the National Eye Institute, a component of the National Institutesof Health. One purpose of the trial is to determine the safety and efficacyof trans-scleral cryotherapy of the peripheral retina in certain low birthweight infants with retinopathy of prematurity.
Analysis of the accumulating early followup data in this trial has led tothe preliminary finding that cryotherapy substantially reduces the numberof unfavorable three-month retinal outcomes (defined as retinal detachment,retinal fold involving the macula, or retrolental tissue) in properly selectedcases. All infants in the study will be followed to monitor long-term results,and no additional infants will be enrolled in the study.
The findings will be reported in detail in the April/May issues of the Archivesof Ophthalmology and Pediatrics, with recommendations for timing of examinationsand selection criteria for patients and eyes appropriate for cryotherapy.In the interim, it is suggested that any premature infants encountered inyour practice who may be a candidate for this therapy be considered for referralto one of the study centers.
This announcement is being sent in advance of journal publication only tophysicians likely to encounter infants with ROP. An official announcementand press conference will be held in conjunction with the publication of studyresults.
Carl Kupfer, M.D.
National Eye Institute
Earl A. Palmer, M.D.
CRYO-ROP Study Chairman
Department of Ophthalmology
Oregon Health Sciences University