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 pre-threshold 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 (24.6% vs 29.0% 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.