Clinical trial NCT05961332: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy
Official title: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration, Age Related
Geographic Atrophy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Comparison of geographic atrophy area measurements by Clarus with standard Spectralis imaging
timeFrame: Up to 75 minutes
measure: Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging
timeFrame: Up to 75 minutes
measure: Comparison of geographic atrophy area measurements between Clarus and Optos
timeFrame: Up to 75 minutes
Secondary outcomes:
measure: Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images
timeFrame: Up to 75 minutes
measure: Prevalence of other autofluorescence abnormalities outside the standard 30 degrees in Clarus and Optos ultrawide field images
timeFrame: Up to 75 minutes
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Amitha Domalpally, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: