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

Last updated: April 9, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Spectralis FAF imaging

Zeiss Clarus 700 imaging

Optos imaging

Clinical Study ID

NCT05961332
2023-0958
Protocol Version 3/20/2025
Protocol Version 6/21/2023
SMPH/OPHTHAL&VIS SCI/FPRC
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofeyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal ormultifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyeshaving subfoveal GA. The presence of concurrent peripapillary atrophy will notexclude subjects from participation

  • Willing to participate as evidenced by signing the written informed consent

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Spectralis FAF imaging
Phase:
Study Start date:
October 06, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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