HealthyCHORALNCT03377075
Study of the Choroidal and Retinal Thickness in Relation to Axial Length.
An observational study of Healthy, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AL measurement and OCT
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteHungary
- Study dates
- 6 Feb 2017to 30 Nov 2018
- Phase
- Observational
- 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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subject with no eye diseases.
Who may be able to join
- 18 years of age or older, but less than 29 years of age
- Caucasian race
- Signed informed consent
Who cannot join
- Known epilepsy
- Inability to act
- Media opacity in the eye that would disturb imaging
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Ophthalmology
Budapest, 1085
About this study
Official title: Study of the Choroidal and Retinal Thickness in Relation to Axial Length in Healthy Young Subjects With Swept-source Optical Coherence Tomography.
The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.
Read the detailed description
The choroid is responsible for the oxygen supply of the outer retina, hence many diseases that affect the retina are originating from the choroid or at later stages influence the choroid as well. The functional efficiency of the choroid in a healthy subject is important. The thickness of the choroid is a marker for the extent of the vessels inside.
With optical coherence tomography (OCT) non-invasive and non-contact measurement of the choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments of OCTs. Its increase wavelength allows deeper penetration than previous models and allows high resolution imaging.
OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE marked commercially available medical device.
The goal of the study is to evaluate the choroidal and the retinal morphology in relation to the length of the eyeball (axial length - AL) in healthy, young adults.
There are several publications on this topic, most of them on asian populations.
In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect on choroidal thickness.
Following informed consent, demographics are recorded, refraction is taken, axial length is measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.
Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on personal data protection. Results are processed with statistical analysis.
- Conditions
- Healthy
- Being tested
- AL measurement, OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL measurementDevice
IOL Master 500 (Carl Zeiss AG, Germany)
OCTDevice
Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Device: AL measurement; Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of choroidal thickness to axial length
Measured: Through study completion, 6 months
Relation of retinal thickness to axial length
Measured: Through study completion, 6 months
Secondary outcomes (2)
Influence of age on results
Measured: Through study completion, 6 months
Influence of gender on results
Measured: Through study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start6 Feb 2017
- Primary completion3 Oct 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Schneider MD, PhD, Semmelweis University
- Investigators
- Miklos Schneider, Principal investigator, Semmelweis University, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377075
- Sponsor's protocol ID
- CHORAL-1249
- Acronym
- CHORAL
- Status last verified
- Feb 2019
- First submitted
- 13 Dec 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Choroidal and Retinal Thickness in Relation to Axial Length in Healthy Young Subjects With Swept-source Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT03377075
- Acronym / sponsor ID
- CHORAL / CHORAL-1249
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Dec 2017 (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.
The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.
Detailed description
The choroid is responsible for the oxygen supply of the outer retina, hence many diseases that affect the retina are originating from the choroid or at later stages influence the choroid as well. The functional efficiency of the choroid in a healthy subject is important. The thickness of the choroid is a marker for the extent of the vessels inside.
With optical coherence tomography (OCT) non-invasive and non-contact measurement of the choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments of OCTs. Its increase wavelength allows deeper penetration than previous models and allows high resolution imaging.
OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE marked commercially available medical device.
The goal of the study is to evaluate the choroidal and the retinal morphology in relation to the length of the eyeball (axial length - AL) in healthy, young adults.
There are several publications on this topic, most of them on asian populations.
In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect on choroidal thickness.
Following informed consent, demographics are recorded, refraction is taken, axial length is measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.
Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on personal data protection. Results are processed with statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: AL measurement, Device: OCT |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subject with no eye diseases.
Key inclusion criteria (3 listed)
- 18 years of age or older, but less than 29 years of age
- Caucasian race
- Signed informed consent
Key exclusion criteria (3 listed)
- Known epilepsy
- Inability to act
- Media opacity in the eye that would disturb imaging
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 |
|---|---|---|
| AL measurementIOL Master 500 (Carl Zeiss AG, Germany) | Device | Healthy subjects |
| OCTChoroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) | Device | Healthy subjects |
Primary outcome
Relation of choroidal thickness to axial length
Time frame: Through study completion, 6 months
Relation of retinal thickness to axial length
Time frame: Through study completion, 6 months
2 secondary outcomes
Influence of age on results
Time frame: Through study completion, 6 months
Influence of gender on results
Time frame: Through study completion, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- 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.
Miklos Schneider principal investigator
Semmelweis University, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Feb 2019. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation of choroidal thickness to axial length (time frame: Through study completion, 6 months). The study lists 2 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 27 Feb 2019.