Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment A Randomized Clinical Trial
Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment A Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2014.2772
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发表时间：
2014-11-01
影响因子：
8.1
通讯作者：
Mintz-Hittner, Helen A.
中科院分区：
文献类型：
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作者：
Geloneck, Megan M.;Chuang, Alice Z.;Mintz-Hittner, Helen A.
重要性早产儿视网膜病变（ROP）往往发展为近视，而那些需要激光治疗的儿童可能发展为高度近视，这具有相当大的临床后果。目的报告在I区或II区后部发展为3期+ ROP或侵袭性后部ROP（APROP）的早产儿的屈光结果。所有婴儿在一项前瞻性、分层、随机、对照、盲法、多中心临床试验中接受玻璃体内贝伐单抗或激光治疗，贝伐单抗消除ROP的血管生成威胁（BEAT-ROP）。在BEAT-ROP临床试验中接受玻璃体内贝伐单抗或激光治疗的儿童，按婴儿随机分组，在平均21/2岁时接受睫状肌麻痹视网膜镜验光。本试验纳入了15家中心，这些中心的儿科和玻璃体视网膜眼科医生均参与了获得机构审查委员会批准的学术中心的3级新生儿重症监护室。在BEAT-ROP临床试验最初招募的150名婴儿（300只眼）中，13名婴儿（26只眼）死亡（6名接受玻璃体内贝伐单抗治疗; 7名接受激光治疗），19只眼接受眼内手术（6名婴儿双侧）。45眼排除了19名婴儿（双侧），留下131名婴儿（255眼，包括21只成功接受第二次复发治疗的眼睛）。干预BEAT-ROP队列的随访。主要结果和测量标准等效球镜屈光结果及其在ROP区域和治疗中的分布。结果131名合格婴儿中有109名可获得屈光211眼（82.7%）。平均（SD）等效球镜屈光度如下：I区，-1.51在接受玻璃体内注射贝伐单抗的52只眼中，屈光度（D）为3.42，激光治疗组35眼D值为7.57后II区，接受玻璃体内贝伐单抗治疗的58只眼为-0.58（2.53）D，接受激光治疗的66只眼为-5.83（5.87）D（P < .001）。在接受玻璃体内贝伐单抗治疗的52只眼中有2只（3.8%）和接受激光治疗的35只眼中有18只（51.4%）发生I区极高度近视（>=-8.00 D）（P <0.001）。在接受玻璃体内贝伐单抗治疗的58只眼中有1只眼（1.7%）发生在后II区，而在接受激光治疗的66只眼中有24只眼（36.4%）发生在后II区（P <0.001）。这种差异可能与玻璃体内贝伐珠单抗存在但激光治疗后很少或不存在的眼前节发育有关。
IMPORTANCE Children born prematurely who develop retinopathy of prematurity (ROP) often developmyopia, and those who require laser treatment may develop very highmyopia, which has considerable clinical consequences.OBJECTIVE To report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3+ ROP or aggressive posterior ROP (APROP).DESIGN, SETTING, AND PARTICIPANTS All infants received intravitreal bevacizumab or laser therapy in a prospective, stratified, randomized, controlled, masked, multicenter clinical trial, Bevacizumab Eliminates the Angiogenic Threat for ROP (BEAT-ROP). Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial, with treatment randomized by infant, underwent cycloplegic retinoscopic refraction at a mean age of 21/2 years. Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial. Of the originally enrolled 150 infants (300 eyes) in the BEAT-ROP clinical trial, 13 infants (26 eyes) died (6 received intravitreal bevacizumab; 7 received laser) and 19 eyes had intraocular surgery (6 infants bilaterally). Thus, 45 eyes (19 infants bilaterally) were excluded, leaving 131 infants (255 eyes, including 21 eyes that received a successful second treatment for recurrence).INTERVENTIONS Follow-up of the BEAT-ROP cohort.MAIN OUTCOMES AND MEASURES Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment.RESULTS Refractions were available for 109 of 131 eligible infants (83.2%) and 211 of 255 eyes (82.7%). Mean (SD) spherical equivalent refractions were as follows: zone I, -1.51 (3.42) diopters (D) in 52 eyes that received intravitreal bevacizumab and -8.44 (7.57) D in 35 eyes that received laser treatment (P < .001); and zone II posterior, -0.58 (2.53) D in 58 eyes that received intravitreal bevacizumab and -5.83 (5.87) D in 66 eyes that received laser treatment (P < .001). Very highmyopia (>=-8.00 D) occurred in zone I in 2 of 52 (3.8%) eyes that received intravitreal bevacizumab and in 18 of 35 (51.4%) eyes that received laser treatment (P < .001). Very highmyopia occurred in zone II posterior in 1 of 58 (1.7%) eyes that received intravitreal bevacizumab and in 24 of 66 (36.4%) eyes that received laser treatment (P < .001).CONCLUSIONS AND RELEVANCE More very highmyopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab. This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment.