Macular Degeneration, Age RelatedCOCO-GANCT05961332
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy
A study testing Spectralis FAF imaging, Optos imaging and Zeiss Clarus 700 imaging in people with Macular Degeneration, Age Related and Geographic Atrophy, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Age Related, Geographic Atrophy
- What is being tested?
- Spectralis FAF imaging, Optos imaging and Zeiss Clarus 700 imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
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.
Read the 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.
- Being tested
- Spectralis FAF imaging, Optos imaging, Zeiss Clarus 700 imaging
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectralis FAF imagingDevice
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 imagingDevice
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 imagingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental | Not described Receives: Device: Spectralis FAF imaging; Device: Optos imaging; Device: Zeiss Clarus 700 imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Measured: Up to 75 minutes
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported)
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Measured: Up to 75 minutes
Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder
Measured: up to 75 mintues
Secondary outcomes (2)
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
Measured: Up to 75 minutes
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
Measured: Up to 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Oct 2023
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular Degeneration, Age RelatedStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitha Domalpally, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961332
- Sponsor's protocol ID
- 2023-0958
- Other IDs
- SMPH/OPHTHAL&VIS SCI/FPRC, Protocol Version 3/20/2025
- Acronym
- COCO-GA
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2023
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
- ClinicalTrials.gov ID
- NCT05961332
- Acronym / sponsor ID
- COCO-GA / 2023-0958
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental | Device: Spectralis FAF imaging, Device: Optos imaging, Device: Zeiss Clarus 700 imaging |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectralis FAF imagingSpectralis 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. | Device | Fundus autofluorescence (FAF) imaging |
| Optos imagingOptos 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. | Device | Fundus autofluorescence (FAF) imaging |
| Zeiss Clarus 700 imagingZeiss 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 | Device | Fundus autofluorescence (FAF) imaging |
Primary outcome
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California
Time frame: 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 devices.
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported)
Time frame: 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 devices.
Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder
Time frame: up to 75 mintues
2 secondary outcomes
Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images
Time frame: Up to 75 minutes
Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images
Time frame: Up to 75 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amitha Domalpally, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectralis FAF imaging, Optos imaging and Zeiss Clarus 700 imaging in people with Macular Degeneration, Age Related and Geographic Atrophy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (time frame: Up to 75 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.