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

Recruiting now · Not applicable

Conditions studied: Optical Coherence Tomography, Optical Coherence Tomography Angiography

In brief

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.

Key facts

Study ID

NCT06043622

Run by

Centre Hospitalier Universitaire, Amiens

People needed

200

Starts

2023-06-12

Expected to finish

2026-09-01

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Amiens University Hospital — Amiens, France (enrolling)

Full record on ClinicalTrials.gov

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