Scott Ingrid U, Figueroa Maria J, Oden Neal L, Ip Michael S, Blodi Barbara A, VanVeldhuisen Paul C
Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
The Emmes Corporation, Rockville, Maryland.
Am J Ophthalmol. 2017 Dec;184:147-156. doi: 10.1016/j.ajo.2017.10.008. Epub 2017 Oct 23.
To describe baseline vision-related function, measured with the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), in patients with macular edema secondary to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2); evaluate the baseline relationship between NEI VFQ-25 scores with visual acuity letter score (VALS) and central retinal thickness; and compare baseline NEI VFQ-25 scores in SCORE2 participants with those in normal-vision reference populations and patients in other retinal vein occlusion trials.
Multicenter, noninferiority randomized controlled trial.
SCORE2 was designed to assess whether intravitreal bevacizumab is noninferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema owing to CRVO or HRVO. SCORE2 enrolled 362 participants, including 305 with CRVO and 57 with HRVO. Analyses were of cross-sectional baseline data. The main outcome measures were baseline NEI VFQ-25 composite and subscale scores.
SCORE2 participants' baseline NEI VFQ-25 composite and subscale scores are significantly lower compared with 3 normal-vision reference populations (P < .01; except for ocular pain score) and similar to patients in other retinal vein occlusion clinical trials. Baseline VALS in the better eye was correlated with baseline NEI VFQ-25 composite and subscale scores of general vision, near activities, role difficulties, dependency, and color vision, with correlations ranging from 0.19 to 0.26 (P < .05 for each score).
CRVO and HRVO patients in SCORE2 had significantly worse baseline patient-reported vision-related function than normal vision populations, despite the disease being primarily unilateral with typically excellent vision in the fellow eye.
在视网膜静脉阻塞比较治疗研究2(SCORE2)中,描述继发于视网膜中央静脉阻塞(CRVO)或半侧视网膜静脉阻塞(HRVO)的黄斑水肿患者的基线视力相关功能(使用美国国立眼科研究所视觉功能问卷(NEI VFQ-25)进行测量);评估NEI VFQ-25评分与视力字母评分(VALS)和视网膜中央厚度之间的基线关系;并将SCORE2参与者的基线NEI VFQ-25评分与正常视力参考人群以及其他视网膜静脉阻塞试验中的患者进行比较。
多中心、非劣效性随机对照试验。
SCORE2旨在评估玻璃体内注射贝伐单抗治疗CRVO或HRVO所致黄斑水肿引起的视力下降是否不劣于玻璃体内注射阿柏西普。SCORE2招募了362名参与者,包括305名CRVO患者和57名HRVO患者。分析采用横断面基线数据。主要结局指标为基线NEI VFQ-25综合评分和子量表评分。
与3个正常视力参考人群相比,SCORE2参与者的基线NEI VFQ-25综合评分和子量表评分显著更低(P <.01;眼部疼痛评分除外),且与其他视网膜静脉阻塞临床试验中的患者相似。较好眼的基线VALS与基线NEI VFQ-25综合评分以及一般视力、近距活动、角色困难、依赖和色觉的子量表评分相关,相关性范围为0.19至0.26(每个评分P <.05)。
SCORE2中的CRVO和HRVO患者报告的基线视力相关功能明显比正常视力人群差,尽管该疾病主要为单侧性,对侧眼通常视力良好。