Comparison of Wide-field Retinal Imaging

Retinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255732
• Other study ID #: UWF
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Oliver Findl, Prof.
• Phone: +43 1 91021-84611
• Email: oliver[@]findl.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK
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, Germany
Comparison of the extent of retinal periphery view between two wide field imaging devices.

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 months