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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Optical Coherence Tomography; Optical Coherence Tomography Angiography

Treatments: Other: Optical coherence tomography angiography; Other: ophthalmological exam

Study type: Interventional

Funder types: Other

Identifiers

NCT06043622

PI2023_843_0089

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

healthy subject vascular density

Experimental group

Treatment:

Other: ophthalmological exam

Other: Optical coherence tomography angiography