Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.
NCT ID: NCT03496597
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
520 participants
OBSERVATIONAL
2018-02-23
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.
NCT04888598
The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
NCT03821753
Endothelial Dysfunction and Diabetes
NCT01097551
Diabetic Retinopathy Screening in General Practice
NCT05276778
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
NCT02538120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients
type 1 diabetes patients
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
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
blood glucose holter
for 40 subjects, implantation of a blood glucose holter monitor for 7 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Dijon Bourgogne
Dijon, , France
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VERGES 2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.