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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06043622
Acronym
COPENBASE
Enrollment
200
Registered
2023-09-21
Start date
2023-06-12
Completion date
2026-09-30
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optical Coherence Tomography, Optical Coherence Tomography Angiography

Keywords

Normative database, Healthy subjects, Optical coherence tomography, Optical coherence tomography angiography, Heidelberg, Vascular density

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.

Interventions

OTHEROptical coherence tomography angiography

Optical coherence tomography angiography

ophthalmological exam

Sponsors

GHPSO de Creil
CollaboratorUNKNOWN
Hôpital Saint Vincent de Paul, Lille
CollaboratorUNKNOWN
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
vascular density of superficial capillary plexus measurementone dayvascular density of superficial capillary plexus measurement
vascular density of deep capillary plexus measurementone dayvascular density of deep capillary plexus measurement
choriocapillaris density in macular zoneone daychoriocapillaris density in macular zone
choriocapillaris density in peripapillary zoneone daychoriocapillaris density in peripapillary zone

Countries

France

Contacts

Primary ContactHa-Chau TRAN, Pr
tran.chau@chu-amiens.fr03 22 08 92 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026