Eye Physicians of Central Florida, Maitland, Florida.
Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts; Rebion Inc, Boston, Massachusetts.
J AAPOS. 2021 Aug;25(4):214.e1-214.e7. doi: 10.1016/j.jaapos.2021.02.011. Epub 2021 Jul 9.
To report the results of a clinical study designed to evaluate the accuracy of the blinq pediatric vision scanner, which detects amblyopia and strabismus directly by means of retinal polarization scanning, unlike other vision screening devices, which infer possible disease based on detection of refractive risk factors.
Subjects 1-20 years of age were prospectively enrolled in this cross-sectional diagnostic accuracy study with planned enrollment of 200. All enrolled subjects were tested by individuals masked to the diagnosis, followed by complete ophthalmologic examination by pediatric ophthalmologists masked to the screening result. Patients previously treated for amblyopia or strabismus were analyzed separately.
The study cohort comprised 193 subjects, 53 of whom had been previously treated, leaving 140 treatment-naïve subjects, including 65 (46%) with amblyopia or strabismus, 11 (8%) with risk factors/suspected binocular vision deficit without amblyopia/strabismus, and 64 (46%) controls. Sensitivity was 100%, with all 66 patients with referral-warranted ocular disease referred. Five patients with intermittent strabismus receiving pass results were deemed "acceptable pass" when considering patient risk factors and amblyogenic potential. Specificity was 91%, with 7 incorrect referrals. Subanalysis of children aged 2-8 years (n = 92) provided similar results (sensitivity 100%; specificity 89%).
In this study cohort, the blinq showed very high sensitivity and specificity for detecting referral-warranted unilateral amblyopia and strabismus. Implementation of the device in vision screening programs could lead to improved rates of disease detection and reduction in false referrals.
报告一项临床研究的结果，该研究旨在评估 blinq 儿童视力扫描仪的准确性，该扫描仪通过视网膜偏振扫描直接检测弱视和斜视，与其他视力筛查设备不同，后者根据屈光危险因素的检测来推断可能的疾病。
本横断面诊断准确性研究前瞻性纳入 1-20 岁的受试者，计划纳入 200 名受试者。所有纳入的受试者均由对诊断不知情的个体进行测试，随后由对筛查结果不知情的小儿眼科医生进行全面眼科检查。对先前接受过弱视或斜视治疗的患者进行了单独分析。
研究队列包括 193 名受试者，其中 53 名曾接受过治疗，留下 140 名未经治疗的受试者，包括 65 名（46%）患有弱视或斜视、11 名（8%）有危险因素/疑似 binocular vision 缺陷但无弱视/斜视，以及 64 名（46%）对照者。敏感性为 100%，所有 66 名有转诊指征的眼部疾病患者均被转诊。考虑到患者的危险因素和致弱视潜力，5 名间歇性斜视且获得通过结果的患者被认为是“可接受的通过”。特异性为 91%，有 7 例错误转诊。对年龄 2-8 岁的儿童（n=92）的亚组分析提供了类似的结果（敏感性 100%；特异性 89%）。
在本研究队列中，blinq 对检测有转诊指征的单侧弱视和斜视具有非常高的敏感性和特异性。在视力筛查项目中实施该设备可能会提高疾病检出率并减少错误转诊。
