Clinical trial NCT06043622: Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
Official title: Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Optical Coherence Tomography
Optical Coherence Tomography Angiography
Keywords: Normative database
Healthy subjects
Optical coherence tomography
Optical coherence tomography angiography
Heidelberg
Vascular density
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: GHPSO de Creil
name: Hôpital Saint Vincent de Paul, Lille
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: vascular density of superficial capillary plexus measurement
timeFrame: one day
measure: vascular density of deep capillary plexus measurement
timeFrame: one day
measure: choriocapillaris density in macular zone
timeFrame: one day
measure: choriocapillaris density in peripapillary zone
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
References: