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基于智能手机的视网膜成像设备作为门诊筛查工具的效用:一项观察性研究方案。

The Utility of a Smartphone-Based Retinal Imaging Device as a Screening Tool in an Outpatient Clinic Setting: Protocol for an Observational Study.

作者信息

Mittal Ajay, Sanchez Victor, Azad Navjot Singh, Zuyev Yaroslav, Robles Rafael, Sherwood Mark

机构信息

University of Florida College of Medicine, Gainesville, FL, United States.

Edward Via College of Osteopathic Medicine - Louisiana, Monroe, LA, United States.

出版信息

JMIR Res Protoc. 2025 Mar 25;14:e52650. doi: 10.2196/52650.

Abstract

BACKGROUND

Glaucoma, a disease leading to the degeneration of retinal ganglion cells, results in changes to the optic nerve head that are often diagnosed late when visual problems arise. With the prevalence of glaucoma surpassing 76 million adults worldwide and with glaucoma being the leading cause of irreversible blindness in the world, the early detection and management of glaucoma is imperative. Digital ophthalmoscopes, such as the D-EYE (D-EYE, Srl), have emerged as a technology that uses smartphone cameras with an attachment on the lens to visualize the retina and optic nerve head without the need for dilation. The purpose of this pilot study is to examine the acceptability and feasibility of a D-EYE digital ophthalmoscope to screen for ocular pathology involving the optic nerve, particularly glaucoma.

OBJECTIVE

This study aimed to demonstrate the effect of a smartphone-based ophthalmoscope as a potential vision screening tool for optic nerve head pathology in participants enrolled in this study. The first specific aim was to determine the ability of the D-EYE smartphone ophthalmoscope to gather high-quality imaging to be used for grading the fundus into low- and high-risk categories for eye pathology. The second specific aim was to determine the difference in the quality of data capture between still retinal images and 30-second retinal video recordings produced by D-EYE smartphone ophthalmoscopes.

METHODS

This observational pilot study enrolled 110 patients receiving routine eye care at the University of Florida Health from February 2019 to February 2022 to assess the use of the D-EYE device in capturing still images and 30-second videos of the bilateral retina and optic nerves of each participant. Study participants completed a survey to gather demographics and past medical history data with a particular focus on previous eye health history. Images were reviewed by 5 ophthalmology residents with interrater reliability analysis performed to assess findings.

RESULTS

Ophthalmology resident review indicated greater visualizability and clarity of the bilateral retina and optic nerves with 30-second videos of retinal imaging compared with still-image ophthalmic capture. Furthermore, an increase in visualizability and clarity allowed for a more accurate measurement of the cup-to-disc ratio, a diagnostic marker for glaucoma. In addition, the likelihood of referral of the glaucomatous and healthy sample groups to ophthalmologists indicated a greater sensitivity of digital ophthalmoscopes in being able to detect retinal abnormalities requiring early intervention and management, supporting the technology's use as a screening tool.

CONCLUSIONS

This investigation suggests that the use of smartphone-based digital ophthalmoscopes can be more effectively applied as a screening tool by capturing 30-second videos compared with still images alone. This novel assessment of an emerging technology in the field of ophthalmology may better equip further research as smartphone camera technology advances.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52650.

摘要

背景

青光眼是一种导致视网膜神经节细胞变性的疾病,会引起视神经乳头的变化,通常在出现视力问题时才被诊断出来,此时往往已到疾病晚期。全球青光眼患者超过7600万成年人,且青光眼是全球不可逆失明的主要原因,因此青光眼的早期检测和管理至关重要。数字检眼镜,如D-EYE(D-EYE公司),已成为一种利用智能手机摄像头并在镜头上附加装置来可视化视网膜和视神经乳头的技术,无需散瞳。这项初步研究的目的是检验D-EYE数字检眼镜用于筛查涉及视神经的眼部病变,特别是青光眼的可接受性和可行性。

目的

本研究旨在证明基于智能手机的检眼镜作为本研究参与者视神经乳头病变潜在视力筛查工具的效果。第一个具体目标是确定D-EYE智能手机检眼镜收集高质量图像用于将眼底分为眼部病变低风险和高风险类别的能力。第二个具体目标是确定D-EYE智能手机检眼镜拍摄的静态视网膜图像与30秒视网膜视频记录之间数据采集质量的差异。

方法

这项观察性初步研究纳入了2019年2月至2022年2月在佛罗里达大学健康中心接受常规眼部护理的110名患者,以评估D-EYE设备在拍摄每位参与者双侧视网膜和视神经的静态图像及30秒视频方面的应用。研究参与者完成了一项调查,以收集人口统计学和既往病史数据,特别关注既往眼部健康史。5名眼科住院医师对图像进行了评估,并进行了评分者间可靠性分析以评估结果。

结果

眼科住院医师的评估表明,与静态图像眼科拍摄相比,视网膜成像的30秒视频能使双侧视网膜和视神经具有更高的可视性和清晰度。此外,可视性和清晰度的提高使得杯盘比(青光眼的诊断标志物)的测量更加准确。此外,青光眼组和健康样本组转诊至眼科医生的可能性表明,数字检眼镜在检测需要早期干预和管理的视网膜异常方面具有更高的敏感性,支持将该技术用作筛查工具。

结论

这项研究表明,与单独使用静态图像相比,通过拍摄30秒视频,基于智能手机的数字检眼镜可更有效地用作筛查工具。随着智能手机摄像头技术的进步,对眼科领域这项新兴技术的这种新颖评估可能会为进一步研究提供更好的支持。

国际注册报告标识符(IRRID):DERR1-10.2196/52650。

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