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Randomized Controlled Trial
. 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

Early Treatment for Retinopathy of Prematurity Cooperative Group  1 ; William V Good, Robert J Hardy, Velma Dobson, Earl A Palmer, Dale L Phelps, Betty Tung, Maryann Redford
Collaborators, Affiliations
Randomized Controlled Trial

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

Early Treatment for Retinopathy of Prematurity Cooperative Group et al. Arch Ophthalmol. 2010 Jun.

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.

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Figures

Figure 1
Figure 1. Research definitions of ROP categories
Figure 2
Figure 2
Standard photograph of plus disease The ETROP Study used this standard photograph for plus disease. At least 2 quadrants of dilation and tortuosity were required for the diagnosis of plus.
Figure 3A
Figure 3A. Algorithm (flow chart) for randomized infants
Figure 3B
Figure 3B. Algorithm for all prethreshold eyes
Figure 4
Figure 4. Distribution of Six-year ETDRS Acuity Outcomes Among Randomized Eyes, by Treatment Assignment
See this image and copyright information in PMC

References

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