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

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.

Study Overview

• Status: Recruiting
• Conditions: Optical Coherence Tomography; Optical Coherence Tomography Angiography
• Intervention / Treatment: Other: Optical coherence tomography angiography; Other: ophthalmological exam

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ha-Chau TRAN, Pr; Phone Number: 03 22 08 92 00; Email: tran.chau@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • Amiens University Hospital
    • Contact: Ha-Chau TRAN, Pr; Phone Number: 03 22 08 92 00; Email: tran.chau@chu-amiens.fr
    • Contact: Sadia ALEM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vascular density of superficial capillary plexus measurement	vascular density of superficial capillary plexus measurement	one day
vascular density of deep capillary plexus measurement	vascular density of deep capillary plexus measurement	one day
choriocapillaris density in macular zone	choriocapillaris density in macular zone	one day
choriocapillaris density in peripapillary zone	choriocapillaris density in peripapillary zone	one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: GHPSO de Creil; Hôpital Saint Vincent de Paul, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Healthy subjects; Optical coherence tomography angiography; Normative database; Heidelberg; Vascular density
• Other Study ID Numbers: PI2023_843_0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No