RecruitingNot ApplicableNCT06043622

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

200 participants

Start Date

Jun 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

OTHEROptical coherence tomography angiography

Optical coherence tomography angiography

OTHERophthalmological exam

ophthalmological exam


Locations(1)

Amiens University Hospital

Amiens, France

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NCT06043622


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