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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03496597

Collaborator

(none)

520

Enrollment

Location

65.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Patients	Procedure: Retinal imaging assessment Procedure: blood glucose holter

Study Design

Study Type:

Observational

Anticipated Enrollment :

520 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 23, 2018

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients type 1 diabetes patients	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 Procedure: blood glucose holter for 40 subjects, implantation of a blood glucose holter monitor for 7 days
Healthy controls non diabetic control subjects of the same age	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
Dyslipidemic controls non-diabetic control participants with familial dyslipidemia	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

Arm

Intervention/Treatment

Patients

type 1 diabetes patients

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

Procedure: blood glucose holter

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

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

Outcome Measures

Primary Outcome Measures

surface of the central retinal avascular zone [inclusion]
measurement of superficial capillary plexus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT03496597

Other Study ID Numbers:

VERGES 2017

First Posted:

Apr 12, 2018

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Mar 10, 2022