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

Study Overview
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Brief Summary
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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.

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

Conditions
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Optical Coherence Tomography, Optical Coherence Tomography Angiography

Intervention / Treatment
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* Other: Optical coherence tomography angiography
* Other: ophthalmological exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity …) OCT-A sufficient quality ≥ 25 (0 = bad quality /40 = excellent quality Not consenting patient Pathological situation or handicap avoiding good installation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy subject vascular density<br> | Other: Optical coherence tomography angiography<br>* Optical coherence tomography angiography<br>Other: ophthalmological exam<br>* ophthalmological exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular density of superficial capillary plexus measurement | vascular density of superficial capillary plexus measurement | one day | 
| vascular density of deep capillary plexus measurement | vascular density of deep capillary plexus measurement | one day | 
| choriocapillaris density in macular zone | choriocapillaris density in macular zone | one day | 
| choriocapillaris density in peripapillary zone | choriocapillaris density in peripapillary zone | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normative database, Healthy subjects, Optical coherence tomography, Optical coherence tomography angiography, Heidelberg, Vascular density