Choroid PhysiologyCVdiNCT02223546
Circadian Macular Volume Changes in the Choroid
An observational study of Choroid Physiology, run by Medical University of Graz at 1 site in Austria.
Trial summary
Choroidal volume measured fluctuates significantly over a 24 hour time frame. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Choroid Physiology
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2013to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Helathy human subjects
Who may be able to join
- age 18-65, signed informed consent form,
Who cannot join
- any ocular pathology, including history of ocular surgery or trauma, use of ocular medication, elevated intraocular pressure (IOP), or significant vitreous floaters. Further exclusion criteria were current use of any systemic medications, history of cardio-vascular disease, diabetes mellitus, or hypertension
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: Pilotstudy: Diurnal Changes in Choroidal Volume
Choroidal volume measured fluctuates significantly over a 24 hour time frame.
Read the detailed description
All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be performed in both eyes after pupil dilation.
Scanning Protocol: This studies choroidal volume measurement protocol has been previously published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a single investigator. To optimize image quality each B-scan will be averaged from at least 25 individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering, Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a 30x25 degree area around the fovea.
Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at 0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for examination at 0 and 3.
OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for automated choroidal volume calculation by the devices build in software. Choroidal thickness is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and the hyper reflective layer behind the large vessels of the choroid (chorio-scleral interface). The devices Software thus generates a three-dimensional choroidal thickness map, divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.
This is considered a pilot study, so explorative data analysis will be performed.
- Conditions
- Choroid Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy subject | healthy subject, every 3 hour measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Choroidal Volume
macular choroidal volume in the central 6mm
Measured: daily average out of measurements every 3 hours within a 24 hour timeframe
Secondary outcomes (1)
Subfoveal Choroidal Thickness
Measured: daily average out of measurements every 3 hours within a 24 hour timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Choroid PhysiologyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Seidel, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223546
- Sponsor's protocol ID
- CVdi
- Acronym
- CVdi
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2014
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotstudy: Diurnal Changes in Choroidal Volume
- ClinicalTrials.gov ID
- NCT02223546
- Acronym / sponsor ID
- CVdi / CVdi
- Conditions
- Choroid Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Choroidal volume measured fluctuates significantly over a 24 hour time frame.
Detailed description
All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be performed in both eyes after pupil dilation.
Scanning Protocol: This studies choroidal volume measurement protocol has been previously published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a single investigator. To optimize image quality each B-scan will be averaged from at least 25 individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering, Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a 30x25 degree area around the fovea.
Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at 0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for examination at 0 and 3.
OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for automated choroidal volume calculation by the devices build in software. Choroidal thickness is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and the hyper reflective layer behind the large vessels of the choroid (chorio-scleral interface). The devices Software thus generates a three-dimensional choroidal thickness map, divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.
This is considered a pilot study, so explorative data analysis will be performed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subject | – | –healthy subject, every 3 hour measurement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Helathy human subjects
Key inclusion criteria (1 listed)
- age 18-65, signed informed consent form,
Key exclusion criteria (1 listed)
- any ocular pathology, including history of ocular surgery or trauma, use of ocular medication, elevated intraocular pressure (IOP), or significant vitreous floaters. Further exclusion criteria were current use of any systemic medications, history of cardio-vascular disease, diabetes mellitus, or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Macular Choroidal Volume
Time frame: daily average out of measurements every 3 hours within a 24 hour timeframe
macular choroidal volume in the central 6mm
1 secondary outcome
Subfoveal Choroidal Thickness
Time frame: daily average out of measurements every 3 hours within a 24 hour timeframe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PMID 25447108Link provided by the sponsor.
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.
Gerald Seidel, MD principal investigator
Medical University of Graz
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 Choroid Physiology, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 1 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 24 Sep 2020. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Macular Choroidal Volume (time frame: daily average out of measurements every 3 hours within a 24 hour timeframe). 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 24 Sep 2020.