Revised indications for the treatment of retinopathy of prematurity: results of the early treatment for retinopathy of prematurity randomized trial.
Revised indications for the treatment of retinopathy of prematurity: results of the early treatment for retinopathy of prematurity randomized trial.
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DOI：
10.1097/00132578-200407000-00018
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发表时间：
2004-07
影响因子：
--
通讯作者：
W. Tasman
中科院分区：
文献类型：
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作者：
W. Tasman
目的探讨早产儿高危阈值前视网膜病变(ROP)早期应用无血管视网膜切除术与常规治疗相比是否能改善视网膜结构和视力。方法双眼高危阈值前ROP患儿(n=317)，随机单眼接受常规治疗的对侧眼(对照眼)早期治疗。在非对称性病例(n=84)中，具有高危阈值前ROP的眼睛被随机分为早期治疗或常规治疗。根据早产儿自然病史队列视网膜病变冷冻治疗多中心试验的模型来确定高危因素。在矫正的9个月大时，由戴面具的测试员使用Teller视力卡程序评估视力。在矫正的6个月和9个月时，检查眼睛的结构结果。使用CHI2分析，结合双眼和不对称病例的数据，对两个治疗组的结果进行比较。结果治疗越早，不良视力的发生率从19.5%下降到14.5%(P=.01)。不良的结构性结果在9个月时从15.6%减少到9.1%(P<；.001)。进一步分析支持对1型ROP进行视网膜消融治疗，定义为I区，任何一期ROP伴Plus病(视网膜后血管的扩张和弯曲程度达到或超过标准照片)；区I，3期ROP无plus病；或区II，2或3期ROP伴plus病。该分析支持对2型ROP采取观望方法，定义为I区，1期或2期ROP，无合并疾病或II区，3期ROP，无合并疾病。只有当发展到1型或阈值ROP时，才应考虑治疗这些眼睛。结论高危阈值前ROP的早期治疗显著减少了不良结局，具有重要的临床意义。更多的分析导致了对ROP眼使用周边视网膜消融术的修改建议。正在进行长期跟踪，以了解出生后第一年注意到的益处是否会持续到儿童时期。
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 chi2 analysis, combining data for bilateral and asymmetric cases. RESULTS Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treatment, 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.