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NCT Number: NCT06043622

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

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.

Recruiting

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Key information

Conditions

Optical Coherence Tomography Optical Coherence Tomography Angiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, 80054, France

Location status: Recruiting

Location contact

Ha-Chau TRAN, Pr

CONTACT

[email protected]

03 22 08 92 00

Sadia ALEM, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography angiography

Other

Optical coherence tomography angiography

ophthalmological exam

Other

ophthalmological exam

Primary outcomes

  1. vascular density of superficial capillary plexus measurement

    Time frame: one day

    vascular density of superficial capillary plexus measurement

  2. vascular density of deep capillary plexus measurement

    Time frame: one day

    vascular density of deep capillary plexus measurement

  3. choriocapillaris density in macular zone

    Time frame: one day

    choriocapillaris density in macular zone

  4. choriocapillaris density in peripapillary zone

    Time frame: one day

    choriocapillaris density in peripapillary zone

Study contacts

Contact information is provided by the study sponsor or research team.

Ha-Chau TRAN, Pr

CONTACT

[email protected]

03 22 08 92 00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • GHPSO de Creil
  • Hôpital Saint Vincent de Paul, Lille

Registry information

Acronym: COPENBASE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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