Final visual acuity results in the early treatment for retinopathy of prematurity study.
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.
Smith-Kettlewell Eye Research Institute, San Francisco, CA 94115, USA. good@ski.org
Good
William V
WV
Hardy
Robert J
RJ
Dobson
Velma
V
Palmer
Earl A
EA
Phelps
Dale L
DL
Tung
Betty
B
Redford
Maryann
M
D000465:Algorithms; D002648:Child; D017679:Cryotherapy / Q000379:methods; D006801:Humans; D007231:Infant, Newborn; D017075:Laser Coagulation / Q000379:methods; D012029:Refraction, Ocular / Q000502:physiology; D012178:Retinopathy of Prematurity / Q000503:physiopathology* / Q000601:surgery*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*
Arch Ophthalmol. 2001 Aug;119(8):1129-33
11483078
Arch Ophthalmol. 1990 Oct;108(10):1408-16
2222274
Pediatrics. 1988 May;81(5):697-706
2895910
Arch Ophthalmol. 2003 Dec;121(12):1684-94
14662586
Dev Med Child Neurol. 1986 Dec;28(6):779-89
3817317
Ophthalmology. 1996 Sep;103(9):1432-7
8841302
Arch Ophthalmol. 2005 Mar;123(3):311-8
15767472
Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1702-8
2211019
Br J Ophthalmol. 2006 Nov;90(11):1378-82
16914473
Arch Ophthalmol. 2003 Dec;121(12):1697-701
14662587
Ophthalmology. 2001 Jun;108(6):1013-4
11382621
Am J Ophthalmol. 1982 Jul;94(1):91-6
7091289
Arch Ophthalmol. 2001 Aug;119(8):1110-8
11483076
Control Clin Trials. 2004 Jun;25(3):311-25
15157731
J AAPOS. 2007 Apr;11(2):148-152
17416324
Arch Ophthalmol. 1988 Apr;106(4):471-9
2895630
Pediatrics. 2000 Nov;106(5):998-1005
11061766
Arch Ophthalmol. 1984 Aug;102(8):1130-4
6547831