Status:
RECRUITING
Predicting the Risk of Diabetic Neurodegenerative Disorders by Artificial Intelligence Tools Based on Retinal Imaging
Lead Sponsor:
Ospedale San Raffaele
Collaborating Sponsors:
Riccardo Sacconi
Ilaria Zucchiatti
Conditions:
Diabete Mellitus
Cognitive Impairment
Eligibility:
All Genders
45+ years
Brief Summary
Diabetic Retinopathy (DR) is the most frequent complication of diabetes, and its presence and severity are related to the appearance of both micro and macrovascular events. Risk profiles have been su...
Eligibility Criteria
Inclusion
- Male or female \> 45 years-old;
- Diagnosis of type 2 DM;
- No previous treatment for diabetic retinopathy;
- Clear ocular media;
- Ability to communicate well with the Investigator and to understand and comply with the requirements of the study;
- Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines and to attend all study visits
Exclusion
- Patients affected by other retinal disease than diabetic retinopathy;
- Presence of diabetic macular edema;
- Presence of proliferative diabetic retinopathy;
- 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;
- Aphakic eye(s) with vitreous in the anterior chamber;
- Neovascular glaucoma;
- Glaucoma caused by congenital angle anomalies;
- Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner;
- Glaucoma secondary to active uveitis;
- Any other ocular condition that would progress in the study period and confound visual acuity assessment a part from diabetic retinopathy;
- Presence of idiopathic or autoimmune-associated uveitis;
- Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve;
- Any intra-ocular surgery on a qualifying eye within three months prior to entry in the study;
- Any prior thermal laser in the macula or intravitreal injections or panphotocoagulation;
- History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery;
- Previous therapeutic radiation in the ocular region in either eye;
- Participation in an investigational drug, biologic, or device study within 6 months prior to baseline \[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary\];
- 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;
- In the opinion of the Investigator, is unlikely to comply with the study protocol.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06541834
Start Date
August 30 2024
End Date
August 30 2026
Last Update
March 14 2025
Active Locations (1)
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1
Ospedale San Raffaele
Milan, Italy, 20138