The early treatment for ROP (ETROP) randomized trial: study results and nursing care adaptations.

The Early Treatment for Retinopathy of Prematurity (ETROP) study, funded by the National Eye Institute, has shown that early treatment of high-risk prethreshold retinopathy of prematurity (ROP) improves retinal and visual outcomes at 9 months corrected age. These favorable study results have yielded new guidelines for treatment of infants with ROP This paper reviews the study methodology and results and outlines the neonatal and ophthalmic nursing interventions influenced by this new treatment schedule. Four critical phases, screening/examination, treatment, evaluation, and follow-up, are identified, and key nursing objectives and tasks are discussed.

The incidence and course of retinopathy of prematurity: findings from the early treatment for retinopathy of prematurity study.

OBJECTIVES: To estimate the incidence of retinopathy of prematurity (ROP) in the Early Treatment for Retinopathy of Prematurity (ETROP) Study and compare these results with those reported in the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study. METHODS: The ETROP Study, as part of its protocol, screened 6998 infants at 26 centers throughout the United States. Serial eye examinations were conducted for infants born weighing <1251 g, making it possible to estimate the frequency of ROP in different birth weight and gestational age categories. ROP was categorized according to the International Classification for ROP. RESULTS: The incidence of any ROP was 68% among infants of <1251 g. The findings were compared with those for infants born in 1986 and 1987 in the CRYO-ROP Study. The overall incidences of ROP were similar in the 2 studies, but there was more zone I ROP in the ETROP Study. Among infants with ROP, more-severe ROP (prethreshold) occurred for 36.9% of infants in the ETROP Study and 27.1% of infants in the CRYO-ROP Study. The gestational age of onset of ROP of different severities has changed very little since the CRYO-ROP Study was conducted. CONCLUSIONS: ROP remains a common important problem among infants with birth weights of <1251 g. The incidence of ROP, time of onset, rate of progression, and time of onset of prethreshold disease have changed little since the CRYO-ROP natural-history study.

Multicenter trial of early treatment for retinopathy of prematurity: study design.

The Early Treatment for Retinopathy of Prematurity (ETROP) study was a randomized, prospective multicenter trial comparing the safety and efficacy of earlier vs. conventionally timed ablation of the peripheral retina for the management of moderate to severe retinopathy of prematurity (ROP). Approximately 7000 infants with birth weights <1251 g were screened at 26 centers over a 2-year period to achieve the sample size of 401 consented infants for the randomized trial. In order to minimize treatment of eyes with ROP that were likely to undergo spontaneous regression of the disease, a risk analysis model, RM-ROP2, was used to select for inclusion in the randomized trial only prethreshold eyes that had a high risk of an adverse outcome. The primary outcome measure was grating visual acuity measured by Teller acuity card testing conducted by masked testers in eyes randomized to earlier treatment vs. eyes randomized to conventional management when infants were 9 months post-term. Results were categorized into favorable (>or=1.85 cycles/degree) vs. unfavorable (<1.85 cycles/degree). The secondary outcome measure was retinal structure, assessed by ophthalmological examinations conducted at 6 and 9 months post-term. Here we describe a unique approach used in the ETROP study to select high-risk prethreshold ROP eyes for randomization and details about design of the study. Study results indicated that earlier intervention in selected high-risk prethreshold eyes results in improved vision in premature infants with ROP.