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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2026-09-30

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.

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Detailed Description

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Conditions

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Optical Coherence Tomography Optical Coherence Tomography Angiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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healthy subject vascular density

Group Type EXPERIMENTAL

Optical coherence tomography angiography

Intervention Type OTHER

Optical coherence tomography angiography

ophthalmological exam

Intervention Type OTHER

ophthalmological exam

Interventions

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Optical coherence tomography angiography

Intervention Type OTHER

ophthalmological exam

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes