Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

Optical coherence tomography angiography (OCT-A) is a determinant progress to study retinal and choroidal vasculature without using a dye injection. OCT-A yields interesting results in different pathologies such as diabetes mellitus, age-related macular degeneration, hypertension blood pressure, particularly by affecting vascular density. Normative database are necessary to compare OCT-A parameters between patients and controls. However, OCT-A devices from different manufactures may give different values for the same subject. It seems to be obvious that each OCT-A device should have its own normative database. In the literature, OCT-A normative databases are developing using different types of devices, but none is available for Heidelberg OCT-A in Caucasians. The purpose of this project is to create a normative database of retinal microvascularisation using Spectralis Heidelberg optical coherence tomography angiography (OCT-A) ® in normal controls.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntary adult subjects or legal representative consenting for minor or subjects under protection

Intra ocular pression ≤ 21mmHg

Spherical refraction comprised between - 6 D and +6 D and/or axial length between 21 and 26mm

Patient affiliated to social security system

Disqualifiers

Ocular diseases: glaucoma, retinal diseases as diabetic retinopathy, age-related macular degeneration, amblyopia, optic neuropathy

Diabetes mellitus

Uncontrolled hypertension blood pressure (> 140/90)

Recent ocular surgery (< 6 months)

Trial design

Design model

Single group

Treatments tested in this trial

  • Optical coherence tomography angiography

    Other intervention

    Optical coherence tomography angiography

  • ophthalmological exam

    Other intervention

    ophthalmological exam

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: healthy subject vascular densityExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

vascular density of superficial capillary plexus measurement

vascular density of superficial capillary plexus measurement

Time frame
one day
2

vascular density of deep capillary plexus measurement

vascular density of deep capillary plexus measurement

Time frame
one day
3

choriocapillaris density in macular zone

choriocapillaris density in macular zone

Time frame
one day
4

choriocapillaris density in peripapillary zone

choriocapillaris density in peripapillary zone

Time frame
one day

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

GHPSO de Creil

Collaborator

Hôpital Saint Vincent de Paul, Lille

Collaborator