PACTR202101512465690已完成未知
Rwanda Artificial Intelligence Diabetic Retinopathy Screening Study (RAIDERS)
未提供0 个研究点目标入组 250 人开始时间: 2020年9月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Recruitment: Consecutive patients with confirmed Type 1 or Type 2 diabetes diagnoses who are attending at a participating diabetes clinic at three sites in Rwanda will receive a patient information leaflet with all the details of the trial while in the waiting room of their diabetes clinic appointment. In addition, a researcher nurse will be available to explained verbally the details of the trial and answer any questions. At the end of their diabetes consultation, their regular clinician will ascertain whether they wish to participate in the trial. If they express an interest, or needed further details, a trained researcher will give further explanation and on reaching agreement to participate, written informed consent will obtained. The individuals will then be enrolled to undergo screening for diabetic retinopathy using retinal imaging. All images will then be uploaded to Cybersight AI for interpretation. ONLY THOSE WHO GET A REFER POSITIVE AI REPORT WILL BE ENROLLED INT THE RCT
- •Summary of inclusion criteria:
- •1)Adults, young people and children who are aged =18years.
- •2) Are Registered with a participating diabetes clinic .
- •3) Have gradeable digital retinal images in at least one eye.
- •4) Give their informed consent for participation.
- •5) Can travel to the referral clinic at RIIO
- •6) Are not involved in any ongoing treatment or trial investigating a treatment with ongoing appointments for care
- •7) For inclusion into the trial: Receive a refer positive Cybersight AI report
排除标准
- •Exclusion criteria will be:
- •1) Patients who do not think that they can return for follow-up e.g. prisoners or visitors to Rwanda ;
- •2)Adults, young people and children who are aged under age 18years.
- •3)Are not registered with a participating diabetes clinic.
- •4) Are ineligible for screening for whatever reason, including inability to be imaged, having ungradable digital retinal images, or have both eyes ungradable eye with no visual potential.
- •5) Do not give consent for participation in the RCT.
- •7)Are not involved in any ongoing treatment or trial investigating a treatment with ongoing appointments for care
- •8) Those who receive a normal Cybersight AI report (Refer negative) will not be enrolled into the trial
- •All these patients will receive appropriate clinical care but will not be included in the trial
研究者
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