A-EYE: A Mixed Quantitative and Qualitative Study to Develop and Evaluate the Application of Artificial Intelligence (AI) Methods Using Retinal Imaging for the Identification of Adverse Retinal Changes Associated With Cancer Therapies.
A-EYE
1 other identifier
observational
350
1 country
1
Brief Summary
This is a data collection study involving the gathering of clinical data and OCT (optical coherence tomography) scans from 350 patients. The purpose of this study is to gather data to help develop an AI algorithm to detect eye abnormalities specifically those related to certain cancer treatments. At the end of the study interviews will be held with expert ophthalmologists to assess the acceptability of implementing AI into clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 9, 2022
November 1, 2022
1.5 years
May 17, 2021
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Measure of the diagnostic accuracy of the AI algorithm against gold standard clinical assessment associated with cancer treatment.
12 months
Secondary Outcomes (1)
Sensitivity of the AI in identifying clinically relevant lesions as defined by an ophthalmologist. Specificity of the AI in identifying clinically relevant lesions as defined by an ophthalmologist.
12 months
Other Outcomes (3)
F1 score of the proposed algorithm compared against baseline algorithms.
13 months
Recorded questionnaire/ interview with ophthalmologist and cancer specialists.
9 months
Number of novel relationships identified
12 months
Interventions
This is an observational study
Eligibility Criteria
Participants will be patients at the Manchester Royal Eye Hospital who meet the eligibility criteria.
You may qualify if:
- Voluntary informed consent.
- Aged at least 18 years.
- Fully registered patient attending the Manchester Royal Eye Hospital
- Patients are having an optical diagnostic imaging as part of their standard of care.
You may not qualify if:
- Patients are excluded from the study if any of the following criteria apply:
- \. Patient who are deemed clinically unable to be scanned by healthcare professional.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester Royal Eye Hospital
Manchester, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Of Ophthalmology and Interface Technologies and Consultant Ophthalmologist
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 25, 2021
Study Start
June 18, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share