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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496597
Other study ID # VERGES 2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2018
Est. completion date August 2023

Study information

Verified date March 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: For the patient group - Patient who has given consent - Type 1 diabetic patient, no retinopathy For the healthy control group - Patient who has given consent - Non-diabetic patient For dyslipidemic control group: - Person who has given consent - Person with familial dyslipidemia Exclusion Criteria: For the patient group - Presence of diabetic retinopathy - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a health insurance scheme For the healthy control group - Ophthalmological history (vascular and degenerative macular conditions) - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a social security scheme For dyslipidemic control group: - Ophthalmological history (vascular and degenerative macular conditions) - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a social security scheme

Study Design


Intervention

Procedure:
Retinal imaging assessment
OCT-angiography Automated measurement program: size of the avascular zone and perifoveolar vascular density of the superficial capillary plexus Eye fundus photography: macular image Measurement of the fractal dimension of the retinal foveolar retina from photographs of the fundus
blood glucose holter
for 40 subjects, implantation of a blood glucose holter monitor for 7 days

Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary surface of the central retinal avascular zone measurement of superficial capillary plexus inclusion