Comparison of Wide-field Retinal Imaging

NCT ID: NCT04255732

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2020-10-31

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.

Conditions

Retinal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Extent of retinal periphery area viewing

For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.

Group Type: OTHER

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Head of Ophthalmology Department, principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oliver Findl, Prof.

Role: PRINCIPAL_INVESTIGATOR

VIROS, Hanusch Hospital Vienna

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Oliver Findl, Prof.

Role: CONTACT

oliver@findl.at

+43 1 91021-84611

Nino Hirnschall, MD, PhD

Role: CONTACT

nino@hirnschall.at

+43 1 91021-84611

Facility Contacts

Oliver Findl, MD, Prof

Role: primary

oliver@findl.at

+43 1 91021-84611

Other Identifiers

UWF

Identifier Type: -

Identifier Source: org_study_id