Eye Diseases
Conditions
Interventions
Immediate Diabetic retinopathy grade feedback using Cybersight Artificial intelligence platform
Delayed feedback after human grading of diabetic retinopathy status at a reading centre
Sponsors
Rwanda International Institute of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measurement - The primary outcome is the attendance rate for treatment and further care within 4 weeks of receiving appointment information in the two arms of the study. Non-attendance is defined as failure to attend any treatment appointment within 4 weeks of being invited for follow up. This outcome will be measured only among those who are disease positive as they are the ones who will have a referral within 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient acceptability and satisfaction measurements of delayed human grading vs immediate grading by AI including perception of impact on time in clinic of including DR screening will bemeasured among providers and patients using a questionnaire designed for the study ;Secondary Outcome Measurements - Diagnostic test accuracy of Cybersight AI platform and human graders diagnoses for identifying any DR needing referral, and for identifying sight-threatening or vision-threatening DR (STDR / VTDR) ; i.e., sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operating characteristic curve (AUC of ROC); and inter-rater agreement compared to gold standard (i.e., adjudicated response agreed to between the retina specialist and the UK NHS grader is the gold standard). ;Inter-rater agreement of level of gradeability of the images as identified in Cybersight AI platform compared to the adjudicated human graders’ grading. | — |
Countries
Rwanda
Contacts
Public ContactJohn Nkurikiye
Rwanda International Institute of Ophthalmology
Outcome results
None listed