This is an application to become one of the cooperating study centers in the Cryotherapy of Retinopathy of Prematurity Study. The CRYO-ROP Study consists of essentially two research components: (1) a clinical trial of the safety and efficacy of cryotherapy in reducing blindness in eyes with severe, high-risk, ROP; and (2) a study of the natural history (in accord with the international classification of ROP) of retinopathy of prematurity in very low birth weight infants (less than 1,251 g). In this proposal, we document the ability of our group of ophthalmologists and neonatologists to enroll, each year, 136 very low birth weight infants who have survived for a least 28 days in the natural history study. We anticipate that 10 of these infants will also develop retinopathy of prematurity severe enough to become eligible for enrollment to the clinical trial, and that an additional 3 patients will be referred to our center for enrollment in the trial from other nurseries in the area (based on referral history over past 5 years).
