Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optical coherence tomography angiography, ophthalmological exam.
- Who it may be relevant to
- Registry conditions: Optical Coherence Tomography, Optical Coherence Tomography Angiography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Optical coherence tomography angiography
Optical coherence tomography angiography - Other ophthalmological exam
ophthalmological exam
Primary outcome measures
- vascular density of superficial capillary plexus measurement [Time frame: one day]
- vascular density of deep capillary plexus measurement [Time frame: one day]
- choriocapillaris density in macular zone [Time frame: one day]
- choriocapillaris density in peripapillary zone [Time frame: one day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Amiens University Hospital — Amiens
Identifiers
NCT: NCT06043622 · PI2023_843_0089