Comparison of Wide-field Retinal Imaging

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.

Study Overview

• Status: Unknown
• Conditions: Retinal Disease
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Extent of retinal periphery area viewing; For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.	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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: retinal imaging; wide field
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: UWF (Other Identifier: University of Wisconsin Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No