COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy
- Conditions
- Geographic AtrophyMacular Degeneration, Age Related
- Registration Number
- NCT05961332
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging Up to 75 minutes 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 Up to 75 minutes 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 Clarus with standard Spectralis imaging Up to 75 minutes 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
Name Time Method Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images Up to 75 minutes 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 Up to 75 minutes The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Wisconsin🇺🇸Madison, Wisconsin, United States