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

March 9, 2022 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surface of the central retinal avascular zone
Time Frame: inclusion
measurement of superficial capillary plexus
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERGES 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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