Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.

NCT03496597 | Unknown

• 1 other identifier: VERGES 2017
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Patients

Outcome Measures

Primary Outcomes (1)

• surface of the central retinal avascular zone

  measurement of superficial capillary plexus

  inclusion

Study Arms (3)

Patients

type 1 diabetes patients

Procedure: Retinal imaging assessment; Procedure: blood glucose holter

Healthy controls

non diabetic control subjects of the same age

Procedure: Retinal imaging assessment

Dyslipidemic controls

non-diabetic control participants with familial dyslipidemia

Procedure: Retinal imaging assessment

Interventions

Retinal imaging assessment PROCEDURE

* 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

Dyslipidemic controls; Healthy controls; Patients

blood glucose holter PROCEDURE

for 40 subjects, implantation of a blood glucose holter monitor for 7 days

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes Type 1 patients followed in the Endocrinology Department of the CHU Dijon Bourgogne or in a diabetology surgery, and non-diabetic controls will be recruited in the Ophthalmology Department of the CHU Dijon Bourgogne

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: February 23, 2018
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

FR (1)