The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications.
The study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed.
The main questions it aims to answer are:
* Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe? * Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?
Diagnosed with type 2 diabetes according to the 1985 WHO criteria.
Age between 35 and 90 years.
Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.
Signed informed consent.
Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).
Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.
Proliferative diabetic retinopathy.
Any ocular surgery within the previous 3 months.
1.000 participants with T2D will be included in this study, in a recruitment period of 12 months.
Cohort
Other
Not listed
Change in Diabetic Retinopathy Staging
Change in score on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS; range 10-85; higher scores indicate worse severity), measured on Optos Ultra-Widefield Fundus Photography.
Diabetic Retinopathy (DR) Progression, measured on the OPTOS Ultra-widefield Fundus Photography (UWF-FP)
Defined as a ≥2-step worsening on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Proportion of participants with ≥15-letter loss in ETDRS Best-Corrected Visual Acuity (BCVA)
≥15-letter loss on the ETDRS BCVA chart (measured with Snellen or LogMAR charts converted to the ETDRS scale).
Incidence of Major Adverse Cardiovascular Events (MACE)
Incidence of myocardial infarction, ischemic stroke, or hospitalization for heart failure, extracted from medical history and confirmed by investigator.
Number of microaneurysms in the central ETDRS area (90°)
Count of microaneurysms within the central ETDRS grading area (90 degrees), assessed by human graders on Optos Ultra-Widefield Fundus Photography images.
Number of microaneurysms in the peripheral retina (90-200°)
Count of microaneurysms in the peripheral retinal area (between 90 and 200 degrees), assessed by human graders on Optos Ultra-Widefield Fundus Photography images.
Presence of hemorrhages in the central ETDRS area
Presence of retinal hemorrhages within the central ETDRS grading area (90 degrees), identified by human graders on Optos Ultra-Widefield Fundus Photography. Reported as the percentage of affected eyes.
Presence of peripheral retinal hemorrhages (90-200°)
Presence of retinal hemorrhages in the peripheral retina (90-200 degrees), assessed through human grading of Optos Ultra-Widefield Fundus Photography images. Reported as the percentage of affected eyes.
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Association for Innovation and Biomedical Research on Light and Image
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
