Diabetic Retinopathy
Conditions
Brief summary
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)
Detailed description
The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR) progression. We aim to characterize both functionally and morphologically initial DR stages and to identify patients at risk of progression to centre involving macular oedema (CME) and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for DR progression. For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed. Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT without the need of a dye injection. In a subgroup of patients we will study neurodegeneration patterns using multifocal ERG examination.
Interventions
None listed
Sponsors
Association for Innovation and Biomedical Research on Light and Image
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus according to 1985 WHO criteria * Aged between 35 years and 80 at baseline in the retrospective period * NPDR level \< 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7 fields CFP) at baseline * BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts) * Informed Consent
Exclusion criteria
* Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations * HbA1C \> 10 % at the Screening or previous 6 months in the previous prospective study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenotypic classification of DR in a 5-year period | 5 years | Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal thickness analysis | 5 years | Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation |
| Ellipsoid zone analysis | 5 years | Degree of integrity of the ellipsoid zone, assessed by SD-OCT |
| Choroidal thickness analysis | 5 years | Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT |
| DR severity level | 5 years | ETDRS grading |
| OCT-Leakage analysis | 5 years | LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage |
| Retinal thickness quantification | 5 years | Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT |
| mfERG assessement | 5 years | P1 implicit time and P1 amplitude by ring |
| SD- OCT- Angiography analysis | 5 years | Vessel analysis, assessed by SD-OCT OCT-Angiography |
Countries
Portugal
Outcome results
None listed