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

University of Wisconsin (UW)

Status: Completed

Conditions: Macular Degeneration, Age Related; Geographic Atrophy

Treatments: Device: Optos imaging; Device: Spectralis FAF imaging; Device: Zeiss Clarus 700 imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05961332

Protocol Version 3/20/2025 (Other Identifier)

SMPH/OPHTHAL&VIS SCI/FPRC (Other Identifier)

2023-0958

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Fundus autofluorescence (FAF) imaging

Experimental group

Treatment:

Device: Zeiss Clarus 700 imaging

Device: Spectralis FAF imaging

Device: Optos imaging