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

Optical Coherence Tomography Clinical Trial

— COPENBASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043622
• Other study ID #: PI2023_843_0089
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Ha-Chau TRAN, Pr
• Phone: 03 22 08 92 00
• Email: tran.chau[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Optical Coherence Tomography
• Optical Coherence Tomography Angiography

Intervention

Other:
• Optical coherence tomography angiography
Optical coherence tomography angiography
• ophthalmological exam
ophthalmological exam

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	GHPSO de Creil, Hôpital Saint Vincent de Paul, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular density of superficial capillary plexus measurement	vascular density of superficial capillary plexus measurement	one day
Primary	vascular density of deep capillary plexus measurement	vascular density of deep capillary plexus measurement	one day
Primary	choriocapillaris density in macular zone	choriocapillaris density in macular zone	one day
Primary	choriocapillaris density in peripapillary zone	choriocapillaris density in peripapillary zone	one day