title: Final visual acuity results in the early treatment for retinopathy of prematurity study.
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.
authors.affiliation: Smith-Kettlewell Eye Research Institute, San Francisco, CA 94115, USA. good@ski.org
authors.forename: William V
authors.initials: WV
authors.lastname: Good
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hardy
authors.forename: Velma
authors.initials: V
authors.lastname: Dobson
authors.forename: Earl A
authors.initials: EA
authors.lastname: Palmer
authors.forename: Dale L
authors.initials: DL
authors.lastname: Phelps
authors.forename: Betty
authors.initials: B
authors.lastname: Tung
authors.forename: Maryann
authors.initials: M
authors.lastname: Redford
mesh_terms: 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*
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