Validation of i-ROP DL to Detect More Than Mild Retinopathy of Prematurity and a Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of Diagnosing Plus Disease of Premature Infants With or Without the Aid of the i-ROP DL in Telemedicine Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of I-ROP DL for mtmROP
研究概览
简要总结
The purpose of the pivotal reader study is to assess the readers' accuracy in diagnosing plus disease versus no plus or pre-plus disease with or without the aid of the i-ROP DL. Ophthalmologists' performance metrics for the following modalities will be evaluated:
- Standard evaluation following the standard of care process ("without i-ROP DL")
- Evaluation following the standard of care process with the aid of the i-ROP DL ("with i-ROP DL") This retrospective multi-reader multi-case (MRMC) study will have an enriched sample of approximately 300 eye cases (1 study eye per subject): 60 plus cases, 120 pre-plus cases and 120 no plus cases. Enrichment is with respect to proportions of plus cases and pre-plus cases.
The primary objective of this study is to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability scores of plus disease statistically significantly non-inferior or superior with the aid of the i-ROP DL versus without the aid of the i-ROP DL. Multiple secondary endpoints are outlined in the next section.
详细描述
This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of approximately 300 cases which will be selected from the library of telemedicine cases collected under Telemedicine Approaches to Evaluating Acute Phase ROP (e-ROP) Study.
All subjects in the library previously provided written informed consent for inclusion in the e-ROP study. As part of the consent process, subjects agreed that image data and supporting documentation could be used for future research and investigations. Only deidentified data and retinal images will be used in this study.
Evaluable cases are defined as subjects who met all protocol case inclusion/exclusion criteria (see Section 6.3.3), and who have a complete set of images for examination, including all 5 recommended fields of view (posterior, nasal, temporal, Superior, and inferior., and have a reference standard diagnosis of acceptable for grding of MTM-ROP. . The quality of each image is categorized as good, adequate, poor, or missing, based on focus, clarity, and field definition.
Measures to ensure subject and reader confidentiality include assignment of unique study and reader ID numbers.
- Sample Size and Case Mix Enriched sample size of approximately 300 cases (subjects) with the following case mix: 60 plus cases, 120 pre-plus cases and 120 no plus cases.
- Case Selection and Targeted Distribution The independent statistician will select cases for this pivotal reader study and cases will be randomly selected to provide representative distributions of race across enrolling sites, to the extent that this can be accomplished using cases in the case library.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification)
- •Signed reader study agreement.
- •Signed informed consent.
- •Successful training on the study protocol and the use of the study software
排除标准
- •Non - U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification)
- •Did not sign reader study agreement.
- •Did not sign informed consent.
- •Did not successfully complete training on the study protocol and the use of the study software
结局指标
主要结局
Sensitivity and Specificity of I-ROP DL for mtmROP
时间窗: 6 months
The primary endpoint of the study will be the sensitivity and specificity of the i-ROP DL system for more than mild ROP.
次要结局
- Sensitivity and specificity of the I-ROP DL system for TR-ROP(6 months)