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

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ClinicalTrials.gov Identifier: NCT03496597
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Patients Procedure: Retinal imaging assessment Procedure: blood glucose holter

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Study Type : Observational
Estimated Enrollment : 160 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 : February 23, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Control
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




Primary Outcome Measures :
  1. surface of the central retinal avascular zone [ Time Frame: inclusion ]
    measurement of superficial capillary plexus



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

For the patient group

  • Patient who has given consent

    • Type 1 diabetic patient, no retinopathy For the control group
  • Patient who has given consent
  • Non-diabetic patient

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496597


Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Bruno VERGES, MD    03.80.29.38.54    bruno.verges@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03496597     History of Changes
Other Study ID Numbers: VERGES 2017
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases