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Article
October 1990

Multicenter Trial of Cryotherapy for Retinopathy of PrematurityOne-Year Outcome-Structure and Function

Arch Ophthalmol. 1990;108(10):1408-1416. doi:10.1001/archopht.1990.01070120056029
Abstract

• This study of the safety and efficacy of cryotherapy in treating severe retinopathy of prematurity registered 9751 infants with birth weights less than 1251 g at 23 study centers. Two hundred ninety-one infants developed a defined threshold retinopathy of prematurity, and cryotherapy was performed in approximately half of the eyes through a randomization protocol. Twelve months after randomization, results of masked grading of fundus photographs of the posterior pole were similar to results obtained 3 months after randomization, and indicated an unfavorable outcome in 25.7% of the eyes that received cryotherapy compared with 47.4% of the control eyes (P<.0001). For the first time, masked Teller Acuity Card assessment of grating acuity was performed in this study group and indicated an unfavorable functional outcome in 35.0% of the treated eyes compared with 56.3% of the control eyes (P<.0001). These results indicate that cryotherapy reduces the risk of unfavorable retinal and functional outcome from threshold retinopathy of prematurity.

References
1.
Cryotherapy for Retinopathy of Prematurity Cooperative Group.  Multicenter trial of cryotherapy for retinopathy of prematurity: three-month outcome . Arch Ophthalmol . 1990;108:195-204.Article
2.
McDonald M, Dobson V, Sebris SL, Baitch L, Varner D, Teller DY.  The acuity card procedure: a rapid test of infant acuity . Invest Ophthalmol Vis Sci . 1985;26:1158-1162.
3.
Dobson V, Quinn GE, Biglan AW, Tung B, Flynn JT, Palmer EA. Acuity card assessment of visual function in the cryotherapy for retinopathy of prematurity trial. Invest Ophthalmol Vis Sci. In press.
4.
Cryotherapy for Retinopathy of Prematurity Cooperative Group.  Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results . Arch Ophthalmol . 1988;106:471-479.Article
5.
Watzke RC, Robertson JE, Palmer EA, Wallace PR, Evans MS, Delaney Soldevilla JE.  Photographic grading in the retinopathy of prematurity trial . Arch Ophthalmol . 1990;108:950-955.Article
6.
Reese AB, King MJ, Owens WC.  A classification of retrolental fibroplasia . Am J Ophthalmol . 1953;36:133-135.
7.
Sebris SL, Dobson V, McDonald MA, Teller DY.  Acuity cards for visual acuity assessment of infants and children in clinical settings . Clin Vis Sci . 1987;2:45-58.
8.
Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Cooperative Group. Manual of Procedures . Springfield, Va: National Technical Information Service; 1985. US Dept of Commerce publication PB 88-163530.
9.
Mantel N, Haenszel W.  Statistical aspects of the analysis of data from retrospective studies of disease . J Natl Cancer Inst . 1959;22:719-748.
10.
Hardy RJ, Davis BR.  The design, analysis and monitoring of an ophthalmological clinical trial . In: American Statistical Association: 1989 Proceedings of Biopharmaceutical Section . Alexandria, Va: American Statistical Association; 248-253.
11.
Majima A.  Studies on retinopathy of prematurity, II: fundus appearance and ocular functions in cicatricial phase of very low birthweight infants . Jpn J Ophthalmol . 1977;21:421-435.
12.
Tasman W.  Late complications of retrolental fibroplasia . Trans Am Acad Ophthalmol . 1979;86:1724-1740.
13.
Fetter WPF, Heersema DJ, Baerts W, Wildervanck de Blecourt Devilee M, van Hof-van Duin J.  Visual acuity and visual field after cryocoagulation for retinopathy of prematurity (ROP) . Pediatr Res . 1989;26:518.Article
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