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

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ClinicalTrials.gov Identifier: NCT06043622
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborators:
GHPSO de Creil
Hôpital Saint Vincent de Paul, Lille
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.

Condition or disease Intervention/treatment Phase
Optical Coherence Tomography Optical Coherence Tomography Angiography Other: Optical coherence tomography angiography Other: ophthalmological exam Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
Actual Study Start Date : June 12, 2023
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: healthy subject vascular density Other: Optical coherence tomography angiography
Optical coherence tomography angiography

Other: ophthalmological exam
ophthalmological exam


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043622


Contacts
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Contact: Ha-Chau TRAN, Pr 03 22 08 92 00 tran.chau@chu-amiens.fr

Locations
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France
Amiens University Hospital Recruiting
Amiens, France, 80054
Contact: Ha-Chau TRAN, Pr    03 22 08 92 00    tran.chau@chu-amiens.fr   
Principal Investigator: Sadia ALEM, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
GHPSO de Creil
Hôpital Saint Vincent de Paul, Lille
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT06043622    
Other Study ID Numbers: PI2023_843_0089
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Normative database
Healthy subjects
Optical coherence tomography
 Optical coherence tomography angiography
Heidelberg
Vascular density