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Retinal and cognitive dysfunction in type 2 diabetes: unraveling the common pathways and identification of patients at risk of dementia

Completed
Conditions
10047060
cognitief functioneren
cognitive impairment
type 2 diabetes
Registration Number
NL-OMON54910
Lead Sponsor
Fundació Hospital Universitari Vall DHebron, VHIR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1. Type 2 diabetes
2. 65 years and older
3. Diabetes duration of at least 5 years
4. Mild to moderate non-proliferative diabetic retinopathy (NPDR) or with no
overt retinopathy
5. Able to provide informed consent

Exclusion Criteria

1. Previous history of stroke or neurodegenerative diseases
2. Severe NPDR, Proliferative DR (PDR), Diabetic Macular Edema (DME) or other
eye disorders affecting vision besides these complications of DR
3. Previous laser photocoagulation
4. Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
5. Subjects with a refractive error = ± 6 D.
6. Media opacities that preclude retinal imaging
7. HbA1C > 10% (86 mmol/mol)
8. Severe systemic illness or personal circumstances that would not make it
possible for the patients to fulfil study protocols

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To assess whether retinal sensitivity measured by microperimetry is able to<br /><br>predict cognitive decline and progression to dementia in MCI T2D patients.</p><br>
Secondary Outcome Measures
NameTimeMethod
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