Retinal Vascular Network and Obstructive Sleep Apnea (ORNET)

February 12, 2026 updated by: Centre Hospitalier Universitaire Dijon

Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea

Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

166

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

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourogne

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

Sampling Method

Non-Probability Sample

Study Population

Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome

Description

Inclusion Criteria:

  • person who has given oral consent
  • person who can be followed throughout the study
  • adult

Patient group:

- Patient seen in sleep apnea screening consultation by a pulmonologist and referred for polysomnography diagnosis of OSA

Control Group:

- Person initially without obstructive sleep apnea syndrome

Exclusion Criteria:

  • a person who is not affiliated to or not a beneficiary of the national health insurance system
  • person subject to a measure of legal protection (curatorship, guardianship)
  • person subject to a safeguard of justice
  • pregnant, parturient or breastfeeding woman
  • adult incapable or unable to consent
  • person with a contraindication to Tropicamide or Neosynephrine
  • person with a history of eye disease affecting ocular circulation (examples: acute anterior ischemic optic neuropathy, retinal central artery occlusion, retinal central vein occlusion, diabetic retinopathy, glaucoma, uncontrolled hypertonia, AMD, severe myopia...)

Control Group:

  • person with a history of chronic lung problems (e.g. COPD, chronic respiratory failure, etc.)

  • person with at least one of the following risk factors for obstructive sleep apnea syndrome:

    • Obesity with IMC≥30
    • Alcohol consumption > 3 glasses per day

Exclusion criteria: positive result in one of the 3 self-questionnaires

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
Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome
Other: complete ophthalmological examination

collection:

  • ophthalmological history and current treatments
  • occular tension measurement
  • measurement of visual acuity (Snellen chart)
  • Axial length measurement
  • Photograph of the posterior segment of the eye
  • 3x3 and 6x6 macular and papillary OCT angiography
Controls
Person without obstructive sleep apnea syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
Time Frame: Change from baseline at 24 months
Change from baseline at 24 months
Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses
Time Frame: Change from baseline at 24 months
Change from baseline at 24 months
Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses
Time Frame: Change from baseline at 24 months
Change from baseline at 24 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 6, 2020

Primary Completion (Actual)

August 22, 2024

Study Completion (Actual)

August 22, 2024

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GABRIELLE 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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