Retinal DiseaseNCT04255732
Comparison of Wide-field Retinal Imaging
A study testing extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK and extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany in people with Retinal Disease, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK and extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 7 Aug 2020to Oct 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 21 years old
- Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients
- Written informed consent prior to any study specific action.
Who cannot join
- Extensive cataract or severe corneal scaring that would affect image quality
- Fixation problems, nystagmus
- pregnancy- for women in reproductive age a pregnancy test will be performed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
Oliver Findl, MD, Prof, +43 1 91021-84611, oliver@findl.at
About this study
Official title: Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing
Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered.
Ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown.
In Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.
Read the detailed description
While both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment.
Aim: To compare two CE-marked imaging systems concerning the extent of retinal periphery area viewing.
We would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients.
Fundus photography will be performed using two ultra-wide-field imaging systems (Optos, Daytona, Optos PLC, Dunfermline, UK and Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany), performed by the same investigator.
All images with sufficient quality will be exported and saved to hard-disk. The difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into Photoshop CS6 image-editing system (Adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.
- Conditions
- Retinal Disease
- Being tested
- extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK, extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany
- Keywords
- retinal imaging, wide field
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UKDevice
Comparison of the extent of retinal periphery view between two wide field imaging devices.
extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, GermanyDevice
Comparison of the extent of retinal periphery view between two wide field imaging devices.
| Study group | Role | What they receive |
|---|---|---|
| Extent of retinal periphery area viewing | Other | For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems. Receives: Device: extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK; Device: extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in retinal periphery viewing between the two devices
Extent of retinal periphery area viewing (the difference in periphery area between the two devices). Images of the same patients will be compared to determine the degree of periphery viewing for the two devices.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Aug 2020
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof., Principal investigator, VIROS, Hanusch Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255732
- Sponsor's protocol ID
- UWF
- Status last verified
- Oct 2020
- First submitted
- 31 Jan 2020
- Last updated
- 6 Oct 2020
- 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing
- ClinicalTrials.gov ID
- NCT04255732
- Acronym / sponsor ID
- UWF
- Conditions
- Retinal Disease
- Keywords
- retinal imaging, wide field
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered.
Ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown.
In Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.
Detailed description
While both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment.
Aim: To compare two CE-marked imaging systems concerning the extent of retinal periphery area viewing.
We would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients.
Fundus photography will be performed using two ultra-wide-field imaging systems (Optos, Daytona, Optos PLC, Dunfermline, UK and Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany), performed by the same investigator.
All images with sufficient quality will be exported and saved to hard-disk. The difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into Photoshop CS6 image-editing system (Adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extent of retinal periphery area viewing | Other | Device: extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK, Device: extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, GermanyFor the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 21 years old
- Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients
- Written informed consent prior to any study specific action.
Key exclusion criteria (3 listed)
- Extensive cataract or severe corneal scaring that would affect image quality
- Fixation problems, nystagmus
- pregnancy- for women in reproductive age a pregnancy test will be performed.
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 |
|---|---|---|
| extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UKComparison of the extent of retinal periphery view between two wide field imaging devices. | Device | Extent of retinal periphery area viewing |
| extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, GermanyComparison of the extent of retinal periphery view between two wide field imaging devices. | Device | Extent of retinal periphery area viewing |
Primary outcome
difference in retinal periphery viewing between the two devices
Time frame: 7 months
Extent of retinal periphery area viewing (the difference in periphery area between the two devices). Images of the same patients will be compared to determine the degree of periphery viewing for the two devices.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Retinal Disease
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
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.
Oliver Findl, Prof. principal investigator
VIROS, Hanusch Hospital Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK and extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany in people with Retinal Disease, run by Prim. Prof. Dr. Oliver Findl, MBA 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 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: status not confirmed, as of the sponsor's last update on 6 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, Prof. (+43 1 91021-84611, oliver@findl.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in retinal periphery viewing between the two devices (time frame: 7 months). 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 6 Oct 2020.