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

Not Applicable

Recruiting

• Conditions: Optical Coherence Tomography; Optical Coherence Tomography Angiography
• Interventions: Other: Optical coherence tomography angiography; Other: ophthalmological exam

• Registration Number: NCT06043622
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy subject vascular density	Optical coherence tomography angiography	-
healthy subject vascular density	ophthalmological exam	-

Primary Outcome Measures

Name	Time	Method
choriocapillaris density in macular zone	one day	choriocapillaris density in macular zone
vascular density of deep capillary plexus measurement	one day	vascular density of deep capillary plexus measurement
vascular density of superficial capillary plexus measurement	one day	vascular density of superficial capillary plexus measurement
choriocapillaris density in peripapillary zone	one day	choriocapillaris density in peripapillary zone

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, France