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Results of the Early Treatment for Retinopathy of Prematurity Randomized Trial

Early Treatment for Retinopathy of Prematurity Cooperative Group

Arch Ophthalmol. 2003;121:1684-1694.

Objective  To determine whether earlier treatment using ablation of the avascular retina in high-risk prethreshold retinopathy of prematurity (ROP) results in improved grating visual acuity and retinal structural outcomes compared with conventional treatment.

Methods  Infants with bilateral high-risk prethreshold ROP (n = 317) had one eye randomized to early treatment with the fellow eye managed conventionally (control eye). In asymmetric cases (n = 84), the eye with high-risk prethreshold ROP was randomized to early treatment or conventional management. High risk was determined using a model based on the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity natural history cohort. At a corrected age of 9 months, visual acuity was assessed by masked testers using the Teller acuity card procedure. At corrected ages of 6 and 9 months, eyes were examined for structural outcome. Outcomes for the 2 treatment groups of eyes were compared using ² analysis, combining data for bilateral and asymmetric cases.

Results  Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treat-ment, from 19.5% to 14.5% (P = .01). Unfavorable structural outcomes were reduced from 15.6% to 9.1% (P<.001) at 9 months. Further analysis supported retinal ablative therapy for eyes with type 1 ROP, defined as zone I, any stage ROP with plus disease (a degree of dilation and tortuosity of the posterior retinal blood vessels meeting or exceeding that of a standard photograph); zone I, stage 3 ROP without plus disease; or zone II, stage 2 or 3 ROP with plus disease. The analysis supported a wait-and-watch approach to type 2 ROP, defined as zone I, stage 1 or 2 ROP without plus disease or zone II, stage 3 ROP without plus disease. These eyes should be considered for treatment only if they progress to type 1 or threshold ROP.

Conclusions  Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes to a clinically important degree. Additional analyses led to modified recommendations for the use of peripheral retinal ablation in eyes with ROP. Long-term follow-up is being conducted to learn whether the benefits noted in the first year after birth will persist into childhood.

The Writing Committee for the Early Treatment for Retinopathy of Prematurity Cooperative Group includes William V. Good, MD; Robert J. Hardy, PhD; Velma Dobson, PhD; Earl A. Palmer, MD; Dale L. Phelps, MD; Michelle Quintos, BA; and Betty Tung, MS. Other members of the Early Treatment for Retinopathy of Prematurity Cooperative Group are listed in a box. The authors have no relevant financial interest in this article with the exception of Dr Dobson, who has received royalties from the sale of Teller acuity cards.

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