Back to resultsCOmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA)
Primary Purpose
Macular Degeneration, Age Related, Geographic Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectralis FAF imaging
Optos imaging
Zeiss Clarus 700 imaging
Sponsored by
About this trial
This is an interventional other trial for Macular Degeneration, Age Related
Eligibility Criteria
Inclusion Criteria: 50 years or older and may be either male or female and may be of any race Established diagnosis of GA due to AMD GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation Willing to participate as evidenced by signing the written informed consent Exclusion Criteria: Unable to tolerate opthalmic imaging Presence of neovascular AMD on OCT as confirmed by an ophthalmologist Presence of significant media opacity preventing adequate retinal imaging Presence of concurrent retinal disease which may confound assessment
Sites / Locations
- University of WisconsinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fundus autofluorescence (FAF) imaging
Arm Description
Outcomes
Primary Outcome Measures
Comparison of geographic atrophy area measurements by Clarus with standard Spectralis imaging
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Comparison of geographic atrophy area measurements between Clarus and Optos
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Secondary Outcome Measures
Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images
The presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices
Prevalence of other autofluorescence abnormalities outside the standard 30 degrees in Clarus and Optos ultrawide field images
The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Full Information
NCT ID
NCT05961332
First Posted
July 18, 2023
Last Updated
October 13, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05961332
Brief Title
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy
Acronym
COCO-GA
Official Title
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device.
Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.
Detailed Description
This study is a single site pilot comparative imaging study in which enrolled participants will undergo dilated fundus exam as per standard of care. Study images will be obtained using Optos ultrawide field fundus autofluorescence (FAF) and both blue and green ultrawide field FAF with Zeiss Clarus. Autofluorescence (AF) imaging will also be performed on the Spectralis as it is currently the gold standard. The goal will be to obtain all images in 60-75 minutes over one visit. Images will be assessed, and area of geographic atrophy measured independently by two experienced readers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Age Related, Geographic Atrophy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fundus autofluorescence (FAF) imaging
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Spectralis FAF imaging
Intervention Description
Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina.
Intervention Type
Device
Intervention Name(s)
Optos imaging
Intervention Description
Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images.
Intervention Type
Device
Intervention Name(s)
Zeiss Clarus 700 imaging
Intervention Description
Zeiss Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm
Primary Outcome Measure Information:
Title
Comparison of geographic atrophy area measurements by Clarus with standard Spectralis imaging
Description
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Time Frame
Up to 75 minutes
Title
Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging
Description
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Time Frame
Up to 75 minutes
Title
Comparison of geographic atrophy area measurements between Clarus and Optos
Description
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Time Frame
Up to 75 minutes
Secondary Outcome Measure Information:
Title
Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images
Description
The presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices
Time Frame
Up to 75 minutes
Title
Prevalence of other autofluorescence abnormalities outside the standard 30 degrees in Clarus and Optos ultrawide field images
Description
The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Time Frame
Up to 75 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50 years or older and may be either male or female and may be of any race
Established diagnosis of GA due to AMD
GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation
Willing to participate as evidenced by signing the written informed consent
Exclusion Criteria:
Unable to tolerate opthalmic imaging
Presence of neovascular AMD on OCT as confirmed by an ophthalmologist
Presence of significant media opacity preventing adequate retinal imaging
Presence of concurrent retinal disease which may confound assessment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Adler
Phone
608-265-7557
Email
amadler1@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amitha Domalpally, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angie Adler
Phone
608-265-7557
Email
amadler1@wisc.edu
First Name & Middle Initial & Last Name & Degree
Amitha Domalpally, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy
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