Title

Multicenter trial of Cryotherapy for Retinopathy of Prematurity: Ophthalmological outcomes at 10 years

Authors

F. J. Elsas, Oregon Health & Science University
M. Collins, Oregon Health & Science University
J. Jones, Oregon Health & Science University
J. A. Kimble, Oregon Health & Science University
L. Kline, Oregon Health & Science University
D. Witherspoon, Oregon Health & Science University
A. M. Roth, Oregon Health & Science University
B. H. Demorest, Oregon Health & Science University
W. S. Gilbert, Oregon Health & Science University
D. Plotsky, Oregon Health & Science University
M. Jaafar, Oregon Health & Science University
A. R. Pilkerton, Oregon Health & Science University
P. A. Mercer, Oregon Health & Science University
R. M. Siatkowski, Oregon Health & Science University
J. Clarkson, Oregon Health & Science University
R. A. Johnson, Oregon Health & Science University
J. Simon, Oregon Health & Science University
J. Zobal-Ratner, Oregon Health & Science University
M. T. Miller, Oregon Health & Science University
C. Cronin, Oregon Health & Science University
M. Daily, Oregon Health & Science University
L. M. Kaufman, Oregon Health & Science University
D. Mittelman, Oregon Health & Science University
N. Santiago, Oregon Health & Science University
M. Shapiro, Oregon Health & Science University
K. Skuran, Oregon Health & Science University
P. Squires, Oregon Health & Science University
C. Vygantas, Oregon Health & Science University
F. D. Ellis, Oregon Health & Science University
D. Bates, Oregon Health & Science University
E. M. Helveston, Oregon Health & Science University
C. C. Barr, Oregon Health & Science University
C. H. Douglas, Oregon Health & Science University

Document Type

Journal Article

Publication Date

1-1-2001

Journal

Archives of Ophthalmology

Volume

119

Issue

8

DOI

10.1001/archopht.119.8.1110

Abstract

Objective: To evaluate outcomes at 10 years after randomization for eyes undergoing cryotherapy vs eyes serving as controls, for patients enrolled in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP). Methods: The randomized cohort originally consisted of 291 preterm children with birth weights less than 1251 g who developed a defined threshold of ROP severity in one or both eyes. Patients with bilateral threshold ROP (n = 240) were randomly assigned to receive cryotherapy to one eye and no cryotherapy to the other eye. Those with ROP of less severity than threshold in the fellow eye ("asymmetric"; n = 51) were randomly assigned to cryotherapy or no cryotherapy in the eye with threshold ROP. Ten years later, a tester who was masked to treatment status of each eye measured distance and near visual acuity, with "unfavorable" outcome being 20/200 or worse. Patients also were evaluated by study-certified ophthalmologists who assessed ROP residua primarily in the posterior pole of the fundus, with unfavorable outcome being a posterior retinal fold or worse. Results: For the 247 children examined, both functional and structural primary outcomes showed fewer unfavorable outcomes in treated vs control eyes: 44.4% vs 62.1% (P<.001) for distance visual acuity and 27.2% vs 47.9% (P<.001) for fundus status. Near acuity results were similar to those for distance (42.5% vs 61.6%; P<.001). Total retinal detachments had continued to occur in control eyes, increasing from 38.6% at 5 1/2 years to 41.4% at 10 years, while treated eyes remained stable (at 22.0%). A previously disturbing subgroup trend that more control eyes than treated eyes had visual acuity of 20/40 or better (in the 5 1/2-year report) was no longer present at 10 years; eyes that received cryotherapy were found at least as likely as control eyes to have 20/40 or better visual acuity. Conclusions: At 10 years, eyes that had received cryotherapy were much less likely than control eyes to be blind. A previous trend for a higher proportion of sighted control eyes than sighted treated eyes to show acuity in the normal range was not confirmed. The results show long-term value from cryotherapy in preserving visual acuity in eyes with threshold ROP.

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