Evaluation of Diagnostic Effectiveness and Reliability of a Telemedical Examination With Occyo One vs Traditional Slit Lamp-based Examination After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- Unexpected Management Changes
研究概览
简要总结
The prospective, (observer) blinded clinical trial at the University Hospital for Ophthalmology includes patients routinely scheduled for cataract surgery at the Medical University of Innsbruck.
Patients are enrolled one week prior to their planned cataract surgery. The participants will undergo a screening in which, in addition to the ophthalmological standard examinations, Occyo One images of the anterior segment of the eye are taken. After surgery, a post-operative follow-up visit takes place and a second set of Occyo One images will be generated.
During the postoperative check-up, the study team at the trial center decides-based on defined criteria (medical history, slit lamp examination results)-whether a change in the subsequent patient management is necessary due to the presence of postoperative complications (unexpected management changes = UMC).
Up on completion of all patient visits/study-specific measurements and data collection, information regarding diagnostic criteria and the Occyo One images are sent to an external, blinded ophthalmologist for telemedical assessment. Based on the available information and images, the blinded ophthalmologist decides whether a change in patient management should have been made or not.
The difference in the detection of an event resulting in a UMC is the primary objective of this clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
- •Patients scheduled to undergo cataract surgery
- •Male or female patient aged ≥ 50 years at time of consent
排除标准
- •1. Woman of childbearing potential (WOCBP)
研究组 & 干预措施
Occyo One Anterior Segment Imaging
Imaging of the anterior segment of the eye for telemedical assessment.
干预措施: Ocular surface imaging (Device)
结局指标
主要结局
Unexpected Management Changes
时间窗: 1 week
Difference of the detection rate of postoperative complications of cataract surgery defined as any event requiring unexpected management changes (UMC) comparing physical slit lamp examination to independent Occyo One image-based telemedical diagnosis by a blinded examiner.
次要结局
- Efron Grading(1 week)
- Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema(1 week)
- National Eye Institute (NEI) Grading Scale(1 week)