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Arch Ophthalmol. 2010 Jun;128(6):663-71. doi: 10.1001/archophthalmol.2010.72. Epub 2010 Apr 12.

Final visual acuity results in the early treatment for retinopathy of prematurity study.

Collaborators (221)

Madan A, Ball MB, Hall JY, Good WV, Gancasz J, Durand D, Slagle T, Smith G, Shapiro M, Santiago N, Bhat R, Kaufman L, Miller M, Mittelman D, Neely D, Hynes EA, Plager D, Barr CC, Bottorff M, Whittington GK, Fishman PH, Rychwalski PJ, Gordon RA, Neff DS, Diamond JG, Gill WL, Preslan MW, Powdrill K, Hutcheson KA, Jones E, Steidl SM, Waeltermann JM, Repka MX, Shepard JA, Donahue P, Aucott SW, Collins ML, Gilmore MM, Handa JT, VanderVeen DK, Mansfield T, MacKinnon B, Cole CH, Fraioli A, Hunter D, McCabe O, Petersen R, Strominger MB, MacKinnon S, Johnson R, Tyedmers M, Baker J, Cumming K, Manatrey P, Bedard MP, Casabar R, Capone A, O'Malley E, Rao R, Roarty J, Trese M, Williams G, Summers CG, Cook S, Holleschau A, Maxwell M, Christiansen SP, Brasel D, Davitt BV, Breuer L, Cruz O, Keenan W, Mantych G, Lueder G, Freedman S, Wallace D, Parkman LH, Jones SK, Enyedi L, Goldstein RF, Reynolds JD, Ziemann K, Albert GP, Awner S, Ryan R, Weber PA, Horowitz M, Behrendt C, Combs A, Dweck N, Koty R, LaGamma E, Marmor M, Flynn J, Coki O, Chiang M, Kane S, Krauss A, Lee TC, Lopez RF, Polin R, Phelps DL, Horihan C, Phillips J, Markowitz G, Merriam W, Noel LP, Tingley D, Gearinger M, Rogers GL, Bremer D, Fellows R, Klamfoth S, Arthur B, Cassady CB, Golden R, McGregor ML, Siatkowski RM, Harris C, Yazdanipanah V, Bradford RH, Leonard RE, McCaffree MA, Wheeler DT, Dolphin N, Palmer EA, Stout A, Nichols B, Epley D, Quinn GE, Koh JG, Letterio M, Abbasi S, Edmond JC, Forbes BJ, Maguire AM, Mills MD, Pierce EA, Young TL, Davidson S, Cheng K, Kelchner-Cheng J, Jones J, Bergren R, Doft B, Lobes L, Olsen K, Saunders RA, Purohit D, Stevens L, Lenhart K, Coats DK, Parker ML, Castanes M, Brown A, Edmond J, Garcia-Prats J, Holz E, Jarriel WS, Johnson K, Mandy G, Paysee EA, Rainey AM, Steinkuller PG, Yen KG, Stokes JP, Trigo Y, Gong AK, van Heuven WA, Hoffman R, Bracken S, Harrison DY, Bernstein P, King J, Teske M, Redford M, Mowery RL, Everett DF, Good WV, Quintos M, Hardy RJ, Tung B, Lai D, Tsai G, Dobson V, Hargadon DD, Wood J, Quinn GE, Harvey EM, Connett J, Donovan EF, Hillis A, Holmes JM, Miller JM, Taylor CR, Good WV, Hardy RJ, Redford M, Dobson V, Palmer EA, Phelps DL, Redford M, van Heuven WA, Barr C, Gaynon M, Shapiro M, Wallace D, Davitt BV, Fellows R, Jones J, Cumming K, Neff DS, Shepard JA, Dolphin N, Good WV, Hardy RJ, Dobson V, Palmer EA, Phelps DL, Quintos M, Tung B.

Author information

1
Smith-Kettlewell Eye Research Institute, San Francisco, CA 94115, USA. good@ski.org

Erratum in

  • Arch Ophthalmol. 2012 Jun;130(6):719.

Abstract

OBJECTIVE:

To compare visual acuity at 6 years of age in eyes that received early treatment for high-risk prethreshold retinopathy of prematurity (ROP) with conventionally managed eyes.

METHODS:

Infants with symmetrical, high-risk prethreshold ROP (n = 317) had one eye randomized to earlier treatment at high-risk prethreshold disease and the other eye managed conventionally, treated if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to either early treatment or conventional management. The main outcome measure was ETDRS visual acuity measured at 6 years of age by masked testers. Retinal structure was assessed as a secondary outcome.

RESULTS:

Analysis of all subjects with high-risk prethreshold ROP showed no statistically significant benefit for early treatment (24.3% vs 28.6% [corrected] unfavorable outcome; P = .15). Analysis of 6-year visual acuity results according to the Type 1 and 2 clinical algorithm showed a benefit for Type 1 eyes (25.1% vs 32.8%; P = .02) treated early but not Type 2 eyes (23.6% vs 19.4%; P = .37). Early-treated eyes showed a significantly better structural outcome compared with conventionally managed eyes (8.9% vs 15.2% unfavorable outcome; P < .001), with no greater risk of ocular complications.

CONCLUSIONS:

Early treatment for Type 1 high-risk prethreshold eyes improved visual acuity outcomes at 6 years of age. Early treatment for Type 2 high-risk prethreshold eyes did not. Application to Clinical Practice Type 1 eyes, not Type 2 eyes, should be treated early. These results are particularly important considering that 52% of Type 2 high-risk prethreshold eyes underwent regression of ROP without requiring treatment. Trial Registration clinicaltrials.gov Identifier: NCT00027222.

PMID:
20385926
PMCID:
PMC4162423
DOI:
10.1001/archophthalmol.2010.72
[Indexed for MEDLINE]
Free PMC Article

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