Predicting the Risk of Diabetic Neurodegenerative Disorders by Artificial Intelligence Tools Based on Retinal Imaging

Launched by OSPEDALE SAN RAFFAELE · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how artificial intelligence (AI) can help predict the risk of developing cognitive impairments in people with type 2 diabetes, using images of the retina (the back part of the eye). Diabetic Retinopathy (DR) is a common eye condition in diabetes that can reveal important information about other health issues, including brain health. Researchers believe that by analyzing these retinal images with AI, they can identify patients at risk of cognitive decline earlier than current methods allow.

To participate in this study, you must be over 45 years old, diagnosed with type 2 diabetes, and have clear vision without other eye diseases. The trial will involve about 250 patients from four hospitals in Italy. Participants will have their retinal images taken and monitored over time to see if the AI can effectively predict cognitive issues. This research aims to improve awareness of cognitive complications in diabetes and create better, cost-effective ways to screen for these problems, helping to reduce the overall burden on healthcare systems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female \> 45 years-old;
• • 2. Diagnosis of type 2 DM;
• • 3. No previous treatment for diabetic retinopathy;
• • 4. Clear ocular media;
• • 5. Ability to communicate well with the Investigator and to understand and comply with the requirements of the study;
• • 6. Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines and to attend all study visits
• Exclusion Criteria:
• • 1. Patients affected by other retinal disease than diabetic retinopathy;
• • 2. Presence of diabetic macular edema;
• • 3. Presence of proliferative diabetic retinopathy;
• • 4. Any media opacities, including corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures in the study eye(s). Subject requiring cataract surgery in the next 12 months must be excluded;
• • 5. Aphakic eye(s) with vitreous in the anterior chamber;
• • 6. Neovascular glaucoma;
• • 7. Glaucoma caused by congenital angle anomalies;
• • 8. Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner;
• • 9. Glaucoma secondary to active uveitis;
• • 10. Any other ocular condition that would progress in the study period and confound visual acuity assessment a part from diabetic retinopathy;
• • 11. Presence of idiopathic or autoimmune-associated uveitis;
• • 12. Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve;
• • 13. Any intra-ocular surgery on a qualifying eye within three months prior to entry in the study;
• • 14. Any prior thermal laser in the macula or intravitreal injections or panphotocoagulation;
• • 15. History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery;
• • 16. Previous therapeutic radiation in the ocular region in either eye;
• • 17. Participation in an investigational drug, biologic, or device study within 6 months prior to baseline \[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary\];
• • 18. Has a serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study;
• • 19. In the opinion of the Investigator, is unlikely to comply with the study protocol.