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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043622

Collaborator

GHPSO de Creil (Other), Hôpital Saint Vincent de Paul, Lille (Other)

200

Enrollment

Location

Arm

38.7

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optical Coherence Tomography Optical Coherence Tomography Angiography	Other: Optical coherence tomography angiography Other: ophthalmological exam	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: healthy subject vascular density	Other: Optical coherence tomography angiography Optical coherence tomography angiography Other: ophthalmological exam ophthalmological exam

Arm

Intervention/Treatment

Experimental: healthy subject vascular density

Other: Optical coherence tomography angiography

Optical coherence tomography angiography

Other: ophthalmological exam

ophthalmological exam

Outcome Measures

Primary Outcome Measures

vascular density of superficial capillary plexus measurement [one day]
vascular density of superficial capillary plexus measurement
vascular density of deep capillary plexus measurement [one day]
vascular density of deep capillary plexus measurement
choriocapillaris density in macular zone [one day]
choriocapillaris density in macular zone
choriocapillaris density in peripapillary zone [one day]
choriocapillaris density in peripapillary zone

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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