Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06043622

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-09-26

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

G

GHPSO de Creil

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are creating a normative database of retinal microvascular density using the Spectralis Heidelberg optical coherence tomography angiography (OCT-A) device in healthy adults. OCT-A allows non-invasive imaging of retinal and choroidal blood vessels without dye injection and is useful in studying various eye and systemic conditions like diabetes and age-related macular degeneration. Since different OCT-A devices provide varying measurements, this study aims to establish device-specific normal values for Caucasian individuals using the Heidelberg OCT-A. Participants will undergo optical coherence tomography angiography and a comprehensive eye exam to measure vascular density in different layers of the retina and choroid. The study focuses on assessing the vascular density of the superficial capillary plexus, deep capillary plexus, and choriocapillaris in both macular and peripapillary zones. These assessments will be completed during a single study visit. During the visit, participants will receive an ophthalmological examination including intraocular pressure measurement and OCT-A imaging. Researchers will evaluate the quality of the OCT-A scans and confirm vascular density parameters. The main outcomes measured are vascular density values from these retinal layers, which will be analyzed to build a normative reference. Participants are healthy volunteers and the study involves no treatment or follow-up visits beyond the initial assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo optical coherence tomography angiography and ophthalmological exams to measure vascular density in various eye zones.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, France, 80054

Actively Recruiting

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Research Team

H

Ha-Chau TRAN, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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