Optical Coherence TomographyCOPENBASENCT06043622
Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
A study testing Optical coherence tomography angiography and ophthalmological exam in people with Optical Coherence Tomography and Optical Coherence Tomography Angiography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optical Coherence Tomography, Optical Coherence Tomography Angiography
- What is being tested?
- Optical coherence tomography angiography and ophthalmological exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, 80054
Ha-Chau TRAN, Pr, 03 22 08 92 00, tran.chau@chu-amiens.fr
Sadia ALEM, MD
About this study
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.
- Being tested
- Optical coherence tomography angiography, ophthalmological exam
- Keywords
- Normative database, Healthy subjects, Optical coherence tomography, Optical coherence tomography angiography, Heidelberg, Vascular density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyOther
Optical coherence tomography angiography
ophthalmological examOther
ophthalmological exam
| Study group | Role | What they receive |
|---|---|---|
| healthy subject vascular density | Experimental | Not described Receives: Other: Optical coherence tomography angiography; Other: ophthalmological exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular density of superficial capillary plexus measurement
vascular density of superficial capillary plexus measurement
Measured: one day
vascular density of deep capillary plexus measurement
vascular density of deep capillary plexus measurement
Measured: one day
choriocapillaris density in macular zone
choriocapillaris density in macular zone
Measured: one day
choriocapillaris density in peripapillary zone
choriocapillaris density in peripapillary zone
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start12 Jun 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- GHPSO de Creil, Hôpital Saint Vincent de Paul, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043622
- Sponsor's protocol ID
- PI2023_843_0089
- Acronym
- COPENBASE
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT06043622
- Acronym / sponsor ID
- COPENBASE / PI2023_843_0089
- Keywords
- Normative database, Healthy subjects, Optical coherence tomography, Optical coherence tomography angiography, Heidelberg, Vascular density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- GHPSO de Creil, Hôpital Saint Vincent de Paul, Lille
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subject vascular density | Experimental | Other: Optical coherence tomography angiography, Other: ophthalmological exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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 …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography angiographyOptical coherence tomography angiography | Other | healthy subject vascular density |
| ophthalmological examophthalmological exam | Other | healthy subject vascular density |
Primary outcome
vascular density of superficial capillary plexus measurement
Time frame: one day
vascular density of superficial capillary plexus measurement
vascular density of deep capillary plexus measurement
Time frame: one day
vascular density of deep capillary plexus measurement
choriocapillaris density in macular zone
Time frame: one day
choriocapillaris density in macular zone
choriocapillaris density in peripapillary zone
Time frame: one day
choriocapillaris density in peripapillary zone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography angiography and ophthalmological exam in people with Optical Coherence Tomography and Optical Coherence Tomography Angiography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ha-Chau TRAN, Pr (03 22 08 92 00, tran.chau@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular density of superficial capillary plexus measurement (time frame: one day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.