Comparison of Wide-field Retinal Imaging
Primary Purpose
Retinal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK
extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Disease focused on measuring retinal imaging, wide field
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.
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Extent of retinal periphery area viewing
Arm Description
For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04255732
First Posted
January 31, 2020
Last Updated
October 3, 2020
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT04255732
Brief Title
Comparison of Wide-field Retinal Imaging
Official Title
Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
Keywords
retinal imaging, wide field
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extent of retinal periphery area viewing
Arm Type
Other
Arm Description
For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.
Intervention Type
Device
Intervention Name(s)
extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK
Intervention Description
Comparison of the extent of retinal periphery view between two wide field imaging devices.
Intervention Type
Device
Intervention Name(s)
extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany
Intervention Description
Comparison of the extent of retinal periphery view between two wide field imaging devices.
Primary Outcome Measure Information:
Title
difference in retinal periphery viewing between the two devices
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, Prof.
Phone
+43 1 91021-84611
Email
oliver@findl.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD, PhD
Phone
+43 1 91021-84611
Email
nino@hirnschall.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof.
Organizational Affiliation
VIROS, Hanusch Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, Prof
Phone
+43 1 91021-84611
Email
oliver@findl.at
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Wide-field Retinal Imaging
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