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)
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.
Studieöversikt
Detaljerad beskrivning
Many cancer patients will access new treatments through clinical trials. These treatments have often never been tested in humans and therefore, are likely to have unknown side effects. Some of these side effects include changes to the eye, such as blindness.
Ahead of patients taking part in these trials there is often little planning done to manage potential side effects on the eye. Additionally, accessing the expertise of eye specialists is not always available and often referral to a specialist is only given when eye symptoms have become advanced. These delays in identifying side effects on the eye also delays treatment and follow-up management. Providing patients access to this expertise would help in the detection and management of treatment side effects, however, due to demands on resources this access is not always readily available.
The aim of this study is to create an artificial intelligence (AI) program that can detect changes to the eye related to disease, which, in the future, can be specifically used in cancer patient care. Additionally, developing an AI program to detect cancer related side effects to the eye will go a significant way in easing the burden on the health care system and improve side effects from new cancer treatments.
This study will involve the collection of eye scans and medical data from participants at the Manchester Royal Eye Hospital. These will then be used to develop AI methods to detect changes in the eye related to those seen by patients on cancer treatment. The AI will then be compared with the assessments of eye specialists to assess if they give similar results.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Tariq Aslam
- Telefonnummer: 0161 276 1234
- E-post: tariq.aslam@manchester.ac.uk
Studieorter
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Manchester, Storbritannien
- Rekrytering
- Manchester Royal Eye Hospital
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Kontakt:
- Tariq Aslam
- E-post: tariq.aslam@manchester.ac.uk
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
Patients are eligible for the study if all inclusion criteria are met:
- 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.
Exclusion Criteria:
Patients are excluded from the study if any of the following criteria apply:
1. Patient who are deemed clinically unable to be scanned by healthcare professional.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Measure of the diagnostic accuracy of the AI algorithm against gold standard clinical assessment associated with cancer treatment.
Tidsram: 12 months
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12 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 12 months
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12 months
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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F1 score of the proposed algorithm compared against baseline algorithms.
Tidsram: 13 months
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13 months
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Recorded questionnaire/ interview with ophthalmologist and cancer specialists.
Tidsram: 9 months
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9 months
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Number of novel relationships identified
Tidsram: 12 months
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12 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NHS001768
Plan för individuella deltagardata (IPD)
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