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Clinical Trials/NCT06043622
NCT06043622
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country200 target enrollmentJune 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Optical Coherence Tomography
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
200
Locations
1
Primary Endpoint
choriocapillaris density in macular zone
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2023
End Date
September 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

choriocapillaris density in macular zone

Time Frame: one day

choriocapillaris density in macular zone

vascular density of deep capillary plexus measurement

Time Frame: one day

vascular density of deep capillary plexus measurement

vascular density of superficial capillary plexus measurement

Time Frame: one day

vascular density of superficial capillary plexus measurement

choriocapillaris density in peripapillary zone

Time Frame: one day

choriocapillaris density in peripapillary zone

Study Sites (1)

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