Brucker Julie, Bhatia Vinona, Sahel José-Alain, Girmens Jean-François, Mohand-Saïd Saddek
Tilak Healthcare, 74 Rue de Faubourg Saint Antoine, 75012, Paris, France.
University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25.
The purpose of this study (Tilak Study No: TIL-001) was to evaluate the medical modules on the mobile medical application OdySight and compare them to the gold standard tests for visual acuity, contrast sensitivity, and Amsler Grid.
A total of 120 eyes were evaluated in an open-label, single-arm, prospective, single-site study during which participants performed monocular, gold standard tests for measuring visual acuity (Sloan Early Treatment Diabetic Retinopathy Study [ETDRS] letter chart at 40 cm testing distance and ETDRS letter chart at 4 m testing distance [40-cm and 4-m ETDRS, respectively), contrast sensitivity (Pelli-Robson contrast sensitivity chart [Pelli-Robson test]), and metamorphopsia/scotoma (Amsler Grid) followed by the respective modules on OdySight (also monocular). During this study, both the distance between the device and the patient's eye and room illumination were controlled by the examiner.
A Bland-Altman analysis demonstrated that there was no disagreement between the results of the OdySight visual acuity module and both the 40-cm Sloan ETDRS and 4-m ETDRS tests, with a very low level of bias (0.53 and - 1.53 letters, respectively). The same analysis of contrast sensitivity showed a broader disagreement between the results of the OdySight module and those of the Pelli-Robson test. A McNemar test indicated that there was no significant difference between results obtained by the OdySight Amsler Grid module and those obtained by the paper version for the detection of metamorphopsia and scotoma (p = 1.0 for both).
The results from the TIL-001 study demonstrate good agreement, overall, between the measurements taken by the near visual acuity module and the Amsler grid module of OdySight as compared to currently used gold standards. The contrast sensitivity module of OdySight will require additional investigation. OdySight could be used for remote monitoring of vision between clinic visits and potentially assist in follow-up planning.
Tilak Healthcare funded the study and the Rapid Service Fees.
ClinicalTrials.gov identifier: NCT03457441.
本研究（Tilak研究编号：TIL-001）的目的是评估移动医疗应用程序OdySight上的医学模块，并将其与视力、对比敏感度和阿姆斯勒方格表的金标准测试进行比较。
在一项开放标签、单臂、前瞻性、单中心研究中，共对120只眼睛进行了评估。在此期间，参与者进行了单眼的金标准测试，以测量视力（在40厘米测试距离使用斯隆糖尿病视网膜病变早期治疗研究[ETDRS]字母表，在4米测试距离使用ETDRS字母表[分别为40厘米和4米ETDRS]）、对比敏感度（佩利-罗布森对比敏感度表[佩利-罗布森测试]）以及变形/暗点（阿姆斯勒方格表），随后在OdySight上进行相应模块的测试（也是单眼）。在这项研究中，检查者控制设备与患者眼睛之间的距离以及房间照明。
布兰德-奥特曼分析表明，OdySight视力模块的结果与40厘米斯隆ETDRS和4米ETDRS测试结果之间没有差异，偏差水平非常低（分别为0.53和-1.53字母）。对对比敏感度的相同分析表明，OdySight模块的结果与佩利-罗布森测试结果之间存在更广泛的差异。麦克尼马尔检验表明，OdySight阿姆斯勒方格表模块检测变形和暗点的结果与纸质版结果之间没有显著差异（两者p值均为1.0）。
TIL-001研究的结果表明，总体而言，与目前使用的金标准相比，OdySight的近视力模块和阿姆斯勒方格表模块的测量结果具有良好的一致性。OdySight的对比敏感度模块需要进一步研究。OdySight可用于在门诊就诊期间对视力进行远程监测，并可能有助于后续随访计划。
Tilak Healthcare为该研究和快速服务费提供了资金。
ClinicalTrials.gov标识符：NCT03457441。
