Retinal Ischemia Characterization in Diabetes - "RICHARD"
Portugal60 participantsStarted 2022-03-30
Plain-language summary
Retinal ischemia characterization in diabetes - RICHARD
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diabetes type 2 according to 1985 WHO definition.
* Age over 18 years old.
* NPDR levels ETDRS DRSS (43 with IRMA, 47 or 53), based on the ETDRS criteria - 7 fields CFP and UWF FFA for 43 with IRMA after confirmation by the Reading Centre (CORC).
* Refraction with a spherical equivalent less than 5 diopters
* Able to provide informed consent.
Exclusion Criteria:
* Presence of diabetic macular edema (DME) involving the center of the macula in the study eye and needing immediate treatment.
* Presence of CI-DME defined as central subfield thickness on OCT ≥305 µm if male or ≥290 µm if female on Zeiss Cirrus OCT \[12\] with vision loss and needing immediate treatment.
* Cataract or other eye disease that may interfere with fundus examinations or OCT/OCTA signal strength.
* Age-related macular degeneration, glaucoma, vitreomacular disease, other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter VA during the study.
* Any eye surgery, including laser, and anti-VEGF within a period of 6-months.
* Dilatation of the pupil \> 5 mm.
* HbA1c \> 12% in the last measurement prior to the study visit (V0). Study Eye: Only one eye per subject will be considered for the primary statistical analysis (Study Eye). If both eyes meet the inclusion criteria the study eye will be the one that has a higher level of DR (ETDRS classification). If both eyes have the same ETDRS DRSS grading, the eye wi…
What they're measuring
1
OCTA metrics and predict progression to PDR and/ or CI- DME
Timeframe: Change from baseline to Month 12
2
OCTA metrics and predict progression to PDR and/ or CI- DME
Timeframe: Change from baseline to Month 24
Trial details
NCT IDNCT05112445
SponsorAssociation for Innovation and Biomedical Research on Light and Image