Creating a database of healthy subject vascular density using optical coherence tomography angiography
Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
This study is trying to create a database of healthy people's eye blood vessel patterns using a special imaging technique to help doctors better diagnose and treat eye conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06043622 on ClinicalTrials.gov |
What this trial studies
This project aims to establish a normative database for retinal microvascularization using Spectralis Heidelberg optical coherence tomography angiography (OCT-A) in healthy individuals. By analyzing the vascular density without dye injection, the study seeks to provide essential comparative data for future OCT-A assessments. The database will specifically address the lack of normative values for Caucasian populations using this particular OCT-A device, which is crucial for accurate diagnosis and treatment planning in various ocular conditions.
Who should consider this trial
Good fit: Ideal candidates include healthy adult individuals with specific ocular parameters and no significant ocular diseases.
Not a fit: Patients with existing ocular diseases, diabetes, or recent ocular surgeries are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of OCT-A assessments and improve patient outcomes in ocular health.
How similar studies have performed: While normative databases for OCT-A exist for other devices, this study is novel as it focuses on the Heidelberg OCT-A specifically for Caucasian populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- Amiens University Hospital — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Ha-Chau TRAN, Pr
- Email: tran.chau@chu-amiens.fr
- Phone: 03 22 08 92 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.