多中心冷冻治疗早产儿视网膜病变的10年结果报告

早产儿视网膜病变冷冻治疗合作组

目的：评价一个多中心随机选择对早产儿视网膜病变患儿进行冷冻治疗和对照观察10结果

方法：本研究是随机队列研究，共有291名出生体重小于1251克单眼或者双眼有明确临界的早产儿视网膜病变的婴儿进入研究。双眼均为临界早产儿视网膜病变的240例患儿随机选择一眼进行冷冻治疗，另眼不做处理观察。另一些（51例）一侧眼早产儿视网膜病变不太严重不到临界状态的眼随机选择有临界病变的进行冷冻或者不冷冻。10年以后由一名不知道治疗分组情况的研究者检查患儿的远近视力，如果视力不超过20/200即认为结果不良。同时一名本研究认证的眼科医生检查患儿的眼底后极部早产儿视网膜病变残余物情况，如果后极部有皱褶或更差者认为结果不良。

结果：一共检查了247名儿童，初步结果显示不论功能还是结构结果治疗组与对照相比结果不良者更少，远视力44.4%比62.1%(P<.001)，眼底检查 27.2%比47.9% (P<.001)，近视力与远视力结果类似42.5% 比 61.6%（P<.001）。对照眼中视网膜脱离持续发生，患病率从5年半38.6%增加至10年时41.4%，而治疗眼的视网膜脱离患病率一直稳定在22.2%。早先在5年半随诊时还存在的对照组视力好于20/40的偏差趋势在10年随诊时已经不复存在。10年后冷冻治疗组的视力好于20/40的至少与对照眼相似。

结论：10年后，冷冻治疗眼与对照眼相比更不容易盲。不能证实早先更多的视力在正常范围的眼进入了对照组而非治疗组。本研究结果显示了冷冻治疗临界早产儿视网膜病变的保护视力的长期效用。

Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Ophthalmological Outcomes at 10 Years Cryotherapy for Retinopathy of Prematurity Cooperative Group

Objective To evaluate outcomes at 10 years after randomization for eyes undergoing cryotherapy vs eyes serving as controls, for patients enrolled in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP).

Methods The randomized cohort originally consisted of 291 preterm children with birth weights less than 1251 g who developed a defined threshold of ROP severity in one or both eyes. Patients with bilateral threshold ROP (n = 240) were randomly assigned to receive cryotherapy to one eye and no cryotherapy to the other eye. Those with ROP of less severity than threshold in the fellow eye ("asymmetric"; n = 51) were randomly assigned to cryotherapy or no cryotherapy in the eye with threshold ROP. Ten years later, a tester who was masked to treatment status of each eye measured distance and near visual acuity, with "unfavorable" outcome being 20/200 or worse. Patients also were evaluated by study-certified ophthalmologists who assessed ROP residua primarily in the posterior pole of the fundus, with unfavorable outcome being a posterior retinal fold or worse.

Results For the 247 children examined, both functional and structural primary outcomes showed fewer unfavorable outcomes in treated vs control eyes: 44.4% vs 62.1% for distance visual acuity and 27.2% vs 47.9% for fundus status. Near acuity results were similar to those for distance (). Total retinal detachments had continued to occur in control eyes, increasing from 38.6% at 5? years to 41.4% at 10 years, while treated eyes remained stable (at 22.0%). A previously disturbing subgroup trend that more control eyes than treated eyes had visual acuity of 20/40 or better (in the 5?-year report) was no longer present at 10 years; eyes that received cryotherapy were found at least as likely as control eyes to have 20/40 or better visual acuity.

Conclusions At 10 years, eyes that had received cryotherapy were much less likely than control eyes to be blind. A previous trend for a higher proportion of sighted control eyes than sighted treated eyes to show acuity in the normal range was not confirmed. The results show long-term value from cryotherapy in preserving visual acuity in eyes with threshold ROP.
Arch Ophthalmol. 2001;119:1110-1118