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

• Conditions: Type 1 Diabetes Patients
• Interventions: Procedure: Retinal imaging assessment; Procedure: blood glucose holter

• Registration Number: NCT03496597
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-23
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Retinal imaging assessment	type 1 diabetes patients
Patients	blood glucose holter	type 1 diabetes patients
Dyslipidemic controls	Retinal imaging assessment	non-diabetic control participants with familial dyslipidemia
Healthy controls	Retinal imaging assessment	non diabetic control subjects of the same age

Primary Outcome Measures

Name	Time	Method
surface of the central retinal avascular zone	inclusion	measurement of superficial capillary plexus

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France