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Recruiting NCT06043622

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

Trial Parameters

Condition Optical Coherence Tomography
Sponsor Centre Hospitalier Universitaire, Amiens
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-06-12
Completion 2026-09
Interventions
Optical coherence tomography angiographyophthalmological exam

Brief Summary

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

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

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