Status:
COMPLETED
Retinal and Cognitive Dysfunction in Type 2 Diabetes
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Queen's University, Belfast
Association for Innovation and Biomedical Research on Light and Image
Conditions:
Retinal Function
Cognitive Dysfunction
Eligibility:
All Genders
65+ years
Brief Summary
The retina shares similar embryologic origin, anatomical features and physiological properties with the brain and hence offers a unique and accessible "window" to study the correlates and consequences...
Detailed Description
The study consists of two main parts: a cross-sectional part and a longitudinal part, aimed at a) to determine whether functional and/or structural retinal biomarkers or circulating biomarkers are abl...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- 65 years and older
- Diabetes duration of at least 5 years
- No overt retinopathy on fundus examination or fundus images, as determined by the evaluating ophthalmologist, in one or both eyes, and people with mild to moderate non-proliferative diabetic retinopathy (NPDR) as determined by the evaluating phthalmologists using fundus examination by slit-lamp biomicroscopy.
- Able to provide informed consent
- Prospective study:
- In addition to the above, participants enrolled in the prospective longitudinal cohort study should fulfilled the following criteria:
- Diagnosis of MCI confirmed by a neuropsychological test battery (NTB) and a specialized physician. For the control group the absence of MCI will also be confirmed by a neuropsychological test battery (NTB) and a specialized physician.
- Diagnosis of no overt or mild to moderate NPDR (ETDRS DR level 20 to 47) confirmed by the reading centre.
Exclusion
- Previous history of stroke or neurodegenerative diseases.
- Severe NPDR, Proliferative DR (PDR), Diabetic Macular Edema (DME) or other eye disorders affecting vision besides these complications of diabetic retinopathy (DR).
- Previous laser photocoagulation.
- Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
- Subjects with a refractive error ≥ ± 6 D.
- Media opacities that preclude retinal imaging.
- HbA1C \> 10% (86 mmol/mol).
- Severe systemic illness or personal circumstances that would not make it possible for patients to fulfil study protocols.
- Prospective study:
- In addition to the above, participants enrolled in the prospective longitudinal cohort study should fulfilled the following criteria:
- 1\. Established dementia.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT04281186
Start Date
November 16 2020
End Date
December 31 2024
Last Update
March 12 2025
Active Locations (1)
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1
Rafael Simó
Barcelona, Spain, 08035