NCT06043622

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2023Sep 2026

Study Start

First participant enrolled

June 12, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

3.2 years

First QC Date

September 12, 2023

Last Update Submit

September 24, 2024

Conditions

Optical Coherence TomographyOptical Coherence Tomography Angiography

Keywords

Normative databaseHealthy subjectsOptical coherence tomographyOptical coherence tomography angiographyHeidelbergVascular density

Outcome Measures

Primary Outcomes (4)

  • vascular density of superficial capillary plexus measurement

    vascular density of superficial capillary plexus measurement

    one day

  • vascular density of deep capillary plexus measurement

    vascular density of deep capillary plexus measurement

    one day

  • choriocapillaris density in macular zone

    choriocapillaris density in macular zone

    one day

  • choriocapillaris density in peripapillary zone

    choriocapillaris density in peripapillary zone

    one day

Study Arms (1)

healthy subject vascular density

EXPERIMENTAL
Other: Optical coherence tomography angiographyOther: ophthalmological exam

Interventions

Optical coherence tomography angiographyOTHER

Optical coherence tomography angiography

healthy subject vascular density
ophthalmological examOTHER

ophthalmological exam

healthy subject vascular density

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens University Hospital

Amiens, 80054, France

RECRUITING

Central Study Contacts

Ha-Chau TRAN, Pr

CONTACT

03 22 08 92 00tran.chau@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)