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Clinical Trials |

Final Visual Acuity Results in the Early Treatment for Retinopathy of Prematurity Study

Arch Ophthalmol. 2010;128(6):663-671. doi:10.1001/archophthalmol.2010.72.
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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 (24.6% 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00027222

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Figure 1.

Research definitions of retinopathy of prematurity (ROP) categories. CRYO-ROP indicates Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Study; ETROP, Early Treatment for Retinopathy of Prematurity; RM-ROP2, risk management of ROP for prethreshold eyes.

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Figure 2.

Standard photograph of plus disease. The Early Treatment for Retinopathy of Prematurity Study used this standard photograph for plus disease. At least 2 quadrants of dilation and tortuosity were required for the diagnosis of plus disease.

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Figure 3.

Algorithms. A, Flowchart for randomized infants. B, For all prethreshold (PT) eyes.

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Figure 4.

Distribution of 6-year ETDRS acuity outcomes among randomized eyes by treatment assignment. LV indicates low vision.

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