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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03496597
Acronym
AwARD
Enrollment
520
Registered
2018-04-12
Start date
2018-02-23
Completion date
2023-08-31
Last updated
2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Patients

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.

Interventions

PROCEDURERetinal 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

PROCEDUREblood glucose holter

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

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
surface of the central retinal avascular zoneinclusionmeasurement of superficial capillary plexus

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026