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Retinal Vascular Network and Obstructive Sleep Apnea

Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03979001
Acronym
ORNET
Enrollment
166
Registered
2019-06-07
Start date
2020-01-06
Completion date
2024-08-22
Last updated
2026-02-17

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

Conditions

Obstructive Sleep Apnea Syndrome

Brief summary

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.

Interventions

OTHERcomplete 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

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

* 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

Design outcomes

Primary

MeasureTime frame
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexusesChange from baseline at 24 months
Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexusesChange from baseline at 24 months
Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexusesChange from baseline at 24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026