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Comparison of Wide-field Retinal Imaging

Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255732
Enrollment
30
Registered
2020-02-05
Start date
2020-08-07
Completion date
2020-10-31
Last updated
2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

Keywords

retinal imaging, wide field

Brief 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. 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.

Interventions

DEVICEextent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK

Comparison of the extent of retinal periphery view between two wide field imaging devices.

DEVICEextent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany

Comparison of the extent of retinal periphery view between two wide field imaging devices.

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
difference in retinal periphery viewing between the two devices7 monthsExtent 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.

Countries

Austria

Contacts

Primary ContactOliver Findl, Prof.
oliver@findl.at+43 1 91021-84611
Backup ContactNino Hirnschall, MD, PhD
nino@hirnschall.at+43 1 91021-84611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026