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Oxygen is used in the prevention of spontaneous retinopathy of prematurity (ROP) both in premature infants who are diagnosed as being at risk for such disease and in those who have already been diagnosed as having it. ROP, which is characterized by a localized (preferential to the center of the retina) abnormal growth of vessels from the periphery towards the center, and which is caused by a physiologic tendency of the retina to remain immature in premature infants. ROP is severe and often causes blindness in these infants. Oxygen is applied to the external surface of the eye (but not usually to the cornea) to supply more oxygen to the retinas of premature infants.
In its primary role of preventing spontaneous ROP, oxygen is applied to the cornea and conjunctiva of the premature infant for four to six weeks before the infant reaches a gestational age of about 36-37 weeks. The reason for the application of oxygen for so long is that the risk of ROP occurring after 34 weeks gestational age is relatively small. However, it has recently been found that extended applications of oxygen to the eye can be harmful. Specifically, retinopathy of prematurity can occur after 34 weeks gestational age. Also, the negative effects of oxygen use on other aspects of the visual system is a matter of concern.
Experiments have been made to suggest that the use of oxygen may adversely affect retinal development in infants. They found that the development of premature human retina was inhibited in culture by hyperoxia and that the inhibition of retinal development is correlated with increased expression of vascular endothelial growth factor (VEGF), a potent mitogen for vascular endothelial cells. These experiments also suggest that there is an increased risk of ROP after the use of oxygen.
In an effort to address this problem, the U.S. government has issued a final rule making oxygen a drug within the meaning of the Federal Food, Drug and Cosmetics Act. Therefore, oxygen is a new drug, requiring
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