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Extracts from the Manual of Procedures for the 1995-8 LIGHT-ROP clinical trial
by Drs. Reynolds, Spencer, et al.

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Go straight to some highlights on this page:
Exposure of 4 hours caused harm

Exposure of 12 hours caused harm

Exposures of 8 and 48 hours caused harm

Exposures of 2 to 17 minutes caused harm

Nursery light and ROP comparison still unpublished
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REFERENCES
[cited in LIGHT-ROP Manual Section 2]

1. Report of the Technical Advisory Group on the Lighting Environment of Newborn Nurseries. New York State Department of Health. March, 1990.

2. Amold LS, Grad RK: Low birth weight and infant morality: A health policy perspective. NAACOG's Clinical Issues 3:1-12, 1992.

3. Wegman ME: Annual summary of vital Statistics-1991. Pediatrics 90:835-845, 1992.

4. Silverman WA: The statistics of deaths of premature infants. In: Dunham's Premature Infants, Third Edition. New York: Harper & Brothers, 1961.

5. Hack M, Fanaroff AA, Mekatz IR: The low-birth-weight infant-evolution of a changing outlook. N Engi J Med 301:1162-1165,1979.

6. Hack M, Horbar JD, Malloy MH, et al: Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Network. Pediatrics 87:587-597,1991.

7. Yee WFM, Scarpelli EM: Surfactant replacement therapy. Pediatr Pulmonol 1:65-80,1991.

8. Abrarnov I, Hainline I, Lemerise E, Brown AK: Changes in visual functions in children exposed as infants to prolonged illumination. JAm Optom Assoc 56:614- 619,1985

9. Phelps DL: Retinopathy of prematurity: An estimate of visual loss in the United States-1979. Pediatrics 67:924-925,1981.

10. Quinn GE, Dobson V, Repka MX, Reynolds JD, Kiviin J, Davis B, Buckley E, Flynn JT, Palmer EA: Development of myopia in infants with birth weights less than 1251 grams. Ophthalmology 99:329-340, 1992.

11. Reynolds JD: Anisometropic amblyopia in severe posterior retinopathy of prematurity. Binocular Vision 5(3): 153-158, 1990.

12. Overpeck MD, Hoffman HJ, Prager K: lowest birth weight infant and U.S. infant mortality rate: NCHS 1983 link birth-infant death data. Am J Public Health 82:441-444,1992.

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13. Palmer EA, Flynn JT, Hardy RJ, et al: Incidence and early course of retinopathy of prematurity. Ophthalmology 98:1628-1640, 1991.

14. Cryotherapy for Retinopathy of Prematurity Cooperative Group: Multicenter trial of cryotherapy for retinopathy of prematurity: One-year Outcome-Structure and function. ArchOphthalmol 108:1408-16, 1990.

15. Repka MX, Hudak ML, Parsa CF, et al: Calf lung surfactant extract prophylaxis and retinopathy of prematurity. Ophthalmology 99:531 -536, 1992.

16. Repka MX, Hardy RJ, Phelps DL, et al: Surfactant prophylaxis and retinopathy of prematurity. ArchOphthalmol 111:618-620, 1993.

17. Sotolongo L, Ferguson 0, Yedavally S, et al: A comparison of the incidence and severity of retinopathy of prematurity between age and weight matched infants treated with and without surfactant. Invest Ophthalmol Supplement 33(4):No. 1967-27,1992.

18. Holmes JM, Cronin CM, Squires P, Myers TF: A randomized clinical trial of surfactant prophylaxis in retinopathy of prematurity, invest Ophthalmol Supplement 34(4): No. 3685, 1993

19. Majerovics A, Dorfman M, Tanenbaum HL: Incidence of severe retinopathy of prematurity in extremely low birthweight infants given surfactant (calf lung surface extract. (Abstract) Invest Ophthalmol (supp\) 30:107, April 1989.

20. Dunn MS, Shennan AT, Zayack D, Possmayer F: Bovine surfactant replacement therapy in neonates of less than 30 weeks' gestation: A randomized controlled trial of prophylaxis versus treatment. Pediatrics 87:377-386, 1991.

21. Rankin STA, Tubman TRJ, Halliday HL, Johnston SS: Surfactant and ROP Incidence (letter). Ophthalmology 98:1148-1149,1991.

22. Kendig JW, Notter RH, Cox C, et al: Surfactant replacement therapy at birth: final analysis of a clinical trial and comparisons with similar trials. Pediatrics 82:756-762,1988.

23. Ware J, Taeusch HW, Soil RF, McCormick MC: Health and development of outcomes of a surfactant controlled trial: Follow-up at 2 years. Pediatrics 85:1103-1107,1990.

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24. Kendig JW, Noter RH, Cox C, Reubens U, Davis JM, Maniscaico WM, Sinkin RA, Bartoletta A, Dweck HS, Morgan MJ, Risemberg H, Phelps DL, Shapiro DL: A comparison of surfactant as immediate prophylaxis and as rescue therapy in newboms of less than 30 weeks gestation. N Engl J Med 324:865-871, 1991.

25. Hittner H, Kretzer F: Retinopathy of prematurity: Pathogenesis, prevention and treatment. Recent Advances in Perinatal Medicine 2:145-163. Churchill Livingston, 1985.

26. Phelps DL: Visual loss due to retinopathy of prematurity. Lancet 1:606, 1981.

27. Flynn JT: An international classification of retinopathy of prematurity: Clinical experience. Trans Am Ophthalmof Soc 82:218-238, 1984.

28. Flynn JT, Bancalari E, Snyder ES, Goldberg RN, Feuer W, Cassady J, Schiffman J, Feidman HI, Bachynski B, Buckley E, et al: A cohort study of transcutaneous oxygen tension and the incidence and severity of retinopathy of prematurity. N Engi J Med 326(16): 1050-1054, 1992.

29. Hittner HM, Godio LB, Rudolph AJ, et al: Retrolental fibroplasia: Efficacy of vitamin E in a double-blind clinical study of preterm infants. N Engi J Med 305:1365-1371,1981.

30. Phelps DL Vitamin E and retinopathy of prematurity. In: Silverman WA, Flynn JT (eds). Contemporary Issues in Fetal and Neonatal Medicine. 2. Ftetinopathy of Prematurity. Boston: Blackwell, 181-205, 1985.

31. Bieri JG, Gorash LC, Hubbard VS: Medical uses of Vitamin E. N Engi J Med 308:1063-1071,1983.

32. Phelps DL, Rosenbaum AL, lsenberg SJ, Leake RD, Dorey FJ: Tocopherol, efficacy and safety for preventing retinopathy of prematurity: A random ized, controlled, double-masked trial. Pediatrics 79:489-500, 1987.

33. Johnson L, Bowen FW, Abbasi S, Herrmann N, Weston M, Sacks L, Porat R, Stahl G, Peckham G, Delivoria-Papadopoulos M, Quinn G, Schaffer D: Relationship of prolonged pharmacologic serum levels of vitamin E to incidence of sepsis and necrotizing enterocolitis in infants with birth weights 1,500 grams or less. Pediatrics 75:619-38, 1985.

34. Cryotherapy for Retinopathy of Prematurity Cooperative Group: Multicenter trial of cryotherapy for retinopathy of prematurity: Preliminary results. Arch Ophthalmot 106:471-479,1988.

35. Cryotherapy for Retinopathy of Prematurity Cooperative Group: Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: 3H-year outcome-structure and function. ArchOphthalmol 111::339-344, 1993.

36. Cryotherapy for Retinopathy of Prematurity Cooperative Group: Multicenter trial of cryotherapy for retinopathy of prematurity: Three-month outcome. Arch Ophthalmol 108:195-204, 1990.

37. Kalina, RE: Treatment of retinal detachment due to retinopathy of prematurity: Documented disappointment. (Editorial) Ophthalmology 98:3-4, 1991.

38. Trese MT: Visual results and prognostic factors for vision following surgery for Stage V retinopathy of prematurity. Ophthalmology'93:574-579, 1986.

39. DeJaun E, Machemer R: Retinopathy of prematurity. Surgical techniques. Retina 7:63-69,1987.

40. Quinn GE, Dobson V, Barr CC, Davis BR, Flynn JT, Palmer EA, Robertson J, Trese MT: Visual acuity in infants after vitrectomy for severe retinopathy of prematurity. Ophthalmology 98:5-13,1991.

41.Spencer R, Birch EE: Visual results after macular reattachment of eyes with stage 4B and 5 retinopathy of prematurity. Presented at American Academy of Ophthalmology meeting, 1990, Atlanta, GA.

42. Noell WK, Walker VS, Kang BS, et al: Retinal damage by light in rats. Invest Ophthalmology 5:450-473,1966.

43. Marshall J: The susceptible visual apparatus. CRC Press. Boca Raton, FL, 1991

44. Lawwill T: Three major pathologic processes caused by light in the primate retina: a search for mechanisms. Trans Am Ophthalmol Soc 80:517-579, 1982

45.  Rapp LM, Tolman BL, Dhindsa HS: Separate mechanisms for retinal damage b ' ultraviolet A and mid-visible light, invest Ophthalmol Vis SciSV.t 186-1190, 1990. [Note: 4-hour exposure caused harm.]

46. Kremers JJM, van Norren D: Two classes of photochemical damage of the retins Lasers Light Ophthalmol 2:41-52, 1988.

47. Sykes SM, Robison WG, Waxier M, and Kuwabara T: Damage to the monke retina by broad-spectrum fluorescent light. Invest Ophthalmol Vis Sci20:425-4M  [Note: 12-hour exposure caused harm.]

48. Sykes SM, Robison WG Jr, Beri JG: Retinal damage by cyclic light and effect of Vitamin E. DDHS Publ 81-8158, U.S. Food and Drug Administration, Washington, DC, 1982.

49. Robison WG Jr, Kuwabara T: Eye Research. In: HL Roster, JD Small, JG Fox, eds. The Mouse in biomedical research, Volume 4. New York: Academy Press, 1982.

50. Robison WG Jr, Kuwabara T: Light induced alterations of retinal pigment epithelium in black, albino and beige mice. Exp Eye Res 22:549-557, 1976.

51. LaVail MM: Interaction of environmental light and eye pigmentation with inherited retinal degenerations. Vision Res 20: 1173-1177, 1980.

52. Demelle M: Possible implications of photo-oxidation reactions in retinal photodamage. Photochem Photobiol29, 713- ; 1979.

53. Halliwell B, Gutheridge JMC: Free Radicals in Biology and Medicine. Clarendon Press, Oxford, 1985.

54. Noell WK: Possible mechanism of photoreceptor damage by light in mammalian eyes. Vision Res 20:1163-1171,1980. [Note: 8 to 48-hour exposure caused harm.]

55. Ham WT, Mueller HA, Ruffolo JJ, et al: Basic mechanisms underlying the production of photochemical lesions in the mammalian retina. Curr Eye Res 3:165-174,1984. [Note: 2 to 17 minute exposure caused harm.]

56. Frank L and Sosenko IRS: Prenatal development of lung anti-oxidant enzymes ir four species. J Pediatr 110:106-110, 1987.

57. Hill DW and Houseman J: Retinal blood flow in the cat following periods of ligh and darkness. Exp Eye Res 41:219-225, 1985.

58. Dorey CK, Delori FC, Akeo K: Growth of cultured RPE and endothelial cells i{ inhibited by blue light but not by green or red; Curr Eye Res 18:1-9, 1990.

59. Hollyfield JG, Fredrick JM, Rayborn ME: Neurotransmitter properties of the newborn human retina. Invest Ophthalmot Vis Sci 24:893-897, 1983.

60. Riley PA and Slater TF: Pathogenesis of retrolental fibroplasia. Lancet 2:265 1969.

61. Nielsen JC, Naash MI, Anderson RE: The regional distribution of vitamins E and C in mature and premature human retinas. Invest Ophthairnoi Vis Sci 29:22-26, 1988.

62. Katz ML and Robison WG Jr: Autoxidative damage to the retina: Potential role in retinopathy of prematurity. In: Flynn JT and Phelps DL (eds). Retinopathy of Prematurity: Problems and Challenge. New York: Alan R. Liss Inc.; 237-248, 1988.

63. Johnson AT, Kretzer FL, Hittner HM, Glazebrook PA, Bridges CDB, Lam DMK: Development of the sub-retinal space in the preterm human eye: Ultrastructure and immunocytochemical studies. J Comp Neurol 233:497-505, 1985.

64. Chader GJ: Interphotoreceptor retinoid-binding protein (IRBP): A model protein for molecular biological and clinically relevant studies. Invest Ophthalmol Vis Sci 30:7-22,1989.

65. Ashton N: The pathogenesis of retrolental fibroplasia. Ophthalmology 86:1695-1699,1979.

66. Patz A: Retrolental fibroplasia (ROP). Trans Opthalmol Soc N Zealand 32:49-54, 1980.

67. Ashton N: Oxygen and the retinal blood vessels. Trans Ophthalmol Soc UK 100:359-362,1980.

68. Kretzer FL, Hittner HM, Johnson AT, et al: Vitamin E and retrolental fibroplasia: ultrastructural support of clinical efficacy. Ann NYAcad Sci 393:145-166, 1982.

69. Kretzer FL, Hunter DG, Mehta RS, et al: Spindle Cells as Vasoformative Elements in the Developing Human Retina: Vitamin E Modulation in Developing and Regenerating Vertebrate Nervous Systems. Alan R. Liss, Inc. NY, NY, 1983. pp. 199-210.

70. Kretzer FL, Hittner HM: - Reply to letter-Vitamin E questioned. Pediatrics 5:734-735,1984.

71. Gottfried AW, Wallace-Lande P, Sherman-Broun S, King J, Coen C: Physical and social environment of newborn infants in special care units. Science 214:673-675, 1981.

72. Landry RJ, Scheldt PC, Hammond RW: Ambient light and phototherapy conditions of eight neonatal care units: a summary report. Pediatrics (Supp.) 75:434-441, 1985.

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73. Moseley MJ, Fielder AR: Open letter: Light toxicity and the neonatal eye. Clin Vision Sci 3:75-82,1988.

74. Moseley MJ, Fielder AR: Illuminance of neonatal units. Arch Dis Child 65:679-682,1990.

75. Lucey JF: Nursery illumination as a factor in neonatal hyperbilirubinemia. Pediatrics 44:155-7, 1969.

76. Korones S: Physical structure and functional organization of neonatal intensive care unity. In: Gottfried AW, Garter JL (eds). Infant Stress Underintensive Care. Baltimore: University Park Press, 1985.

77. MacLeod P, Stern L: Natural variations in environmental illumination in a newborn n u rsery. Pediatrics 50:131-133,1972.

78. American Academy of Pediatrics: Guidelines for Perinatal Care, 2nd edition. Evanton: 1988.

79. Robinson J, Hollins G, Spencer R, Fielder AR: The eyelid: A portable, automated light monitor. Invest Ophthalmol Vis Sci 33 (suppl):2942, 1992.

80. Robinson J, Mosely MJ, Thompson JR, et al: Eyelid opening in preterm neonates. Arch Dis Child 4:943-948,1989.

81. lsenberg SJ, Dany Y, Jotterand V: The pupils of term and preterm infants. Am J Ophthalmol 75-79,1989.

82. Robinson J, Fielder AR: Pupillary diameter and reaction to light in preterm neonates. Arch Dis Child 65:35-Q, 1990.

83. lsenberg SJ, Molarte A, Vasquez M: The fixed and dilated pupils of premature neonates. Am J Ophthalmol 110:168-71, 1990.

84. Fielder AR, Robinson J, Shaw DE: ROP: Location a clue to its pathogenesis? Invest. Ophthalmol Vis Sci (Suppl) 31:584, 1990.

85. Fielder AR, Robinson J, Shaw DE, Ng YK, Moseley MJ: Light and retinopathy of prematurity: Does retinal location offer a clue? Pediatrics 89:648-653, 1992.

86. Lanum J: The damaging effects of lights on the retina. Empirical findings, theoretical and practical implications. Surv Ophthalmol 80:265-279, 1968.

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87. Rapp LM, Williams TP: The role of ocular pigmentation in protecting against retinal light damage. Vision Res 20:1127-1131, 1980.

88. Palmer EA, Plynn JT, Hardy RJ, Phelps DL, et al: Incidence and early course of retinopathy of prematurity, 0p/if/7a/mo/ogy98(11):1628-1640, 1991.

89. Bynoe LA, Gottsch JD, Sada SR, et al: An elevated hematogenous photosensitizer in the pre-term neonate. invest Ophthalmol Vis Sci. In press.

90. Chisolm JJ Jr, Brown DH: Micro-scale photofluorometric determination of "free erythrocyte porphyrin: (protoporphyrin IX). Clin Chem 21:1669-1689, 1975.

91. Bynoe LA, Gottsch JD, Pou S, Rosen GM: Light-dependent generation of superoxide from human erythrocytes. Photochem Photobiol. In press, 1992.

92. Bynoe LA, Pou S, Gottsch JD, Rosen GM: Light-dependent spin trapping of hydroxyl radical from human erythrocytes. Biochem Biophys Ffes Commun 179:1305-1310,1991.

93. Bynoe LA, Gottsch JD, Rencs EV, Harlan JB, Green WR: Light-dependent choriocapillary injury in protoporphric mice: An animal model of hematogenous photosensitization. Invest Ophthalmol {Suw-) 33:918. 1992-

94. Nietson JC, Naash MI, Anderson RE: The regional distribution of vitamins E and C in mature and premature human retinas. Invest Ophthalmol Vis Sci 29:22-26, 1987.

95. Wilhelm J, Armstrong D, Dusse J, et al: Cytochrome biochemistry in the retina and RPE following exposure to oxygen. Invest Ophthalmol Vis Sci (Supp.) 33/34:1185,1992.

96. Sullivan JL: Letter - Retinopathy of prematurity. N Engi J Med 327:648, 1992.

97. Oliver PD, Newsome DA: Mitochondrial superoxide dismutase in mature and developing human retinal pigment epithelium. Invest Ophthalmol Vis Sci 33:1909-1918,1992.

98. Peke GT, Zuckerman R, Green GJ, Weiter JJ: Response of human retinal blood flow to light and dark. Invest Ophthalmol Vis Sci 24:136-141, 1983.

99. Riva CE, Grunwald JE, Petrig BL: Reactivity of the human retinal circulation to darkness: A laser Doppler velocimetry study. Invest Ophthalmol Vis Sci 24:737- 740,1983.

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100. Stefansson E: Retinal oxygen tension is higher in light than dark. Pediatr Res 23:5-8,1988.

101. Fielder AR, Robinson J: Letter to the Editor. Invest Ophthalmol Vis Sci 33:3, 1992.

102. Kremer I, Levitt A, Goldberg G, Wilunsky E, Merlob P, Nissenkorn 1: The effect of light on oxygen-induced vasoproliferative retinopathy in newborn kittens. Invest Ophthalmol Vis Sci 33:1595-1598, 1992.

103. Wesolowski E, Smith LEH: Effect of light on oxygen induced retinopathy in the mouse. Invest Ophthalmol Vis Sci 35:112-119, 1994.

104. Sadda SR, Yu YS, DeJaun E, Rencs EV, Green WR, Gottsch JD: Photosensitization-induced retinopathy in the newborn beagle. Invest Ophthalmol Vis Sci 35:1202-1211,1994.

105. Hepner WR, Krause AC, Davis ME: Retrolental fibroplasia and light. Pediatrics 3:824-828,1949.

106. Locke JC, Reese AB: Retrolental fibroplasia: The negative role of light, mydriatics and the ophthalmoscopic examination in its etiology. Arch Ophthalmol 48:44-47, 1952.

107. Glass P, Avery GB, Subramianian KNS, Keys MP, Friendly DS: Effect of bright light in the hospital nursery on the incidence of retinopathy of prematurity. N Engi J Med3t 3:410-414, 1985.

108. Stobie PE: Bright light and retinopathy of prematurity. Letter to the Editor. N Engi J Med 314:448-449, 1986.

109. Ackerman B, Sherwonit E, Williams J: Reduced incidental light exposure: Effect on the development of retinopathy of prematurity in low birth weight infants. Pediatrics 83:958-962,1989.

110. Seiberth V, Linderkamp 0, Knorz MC, Liesenhoff H: Light and acute retinopathy of prematurity: A controlled clinical trial. Invest Ophthalmol Vis Sci (Supp.) 33(4): 1970-30,1992.

111. Repka MX, Fulton AB, Petersen RA, Robinson J, Simmons K: Retinopathy of prematurity and light. Unpublished data.  [Note: This comparison between the blinding rates in two nurseries with different light intensities remains unpublished.]

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