COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy

Geographic Atrophy Clinical Trial

— COCO-GA  

Official title:

COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961332
• Other study ID #: 2023-0958
• Secondary ID: SMPH/OPHTHAL&VIS
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: Angie Adler
• Phone: 608-265-7557
• Email: amadler1[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Device:
• Spectralis FAF imaging
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.
• Optos imaging
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.
• Zeiss Clarus 700 imaging
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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 75 minutes
Primary	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.	Up to 75 minutes
Primary	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.	Up to 75 minutes
Secondary	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	Up to 75 minutes
Secondary	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	Up to 75 minutes