Retinal DiseaseCOCO-IRDNCT06380075
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
A study testing Spectralis FAF imaging, Optos imaging and Clarus imaging in people with Retinal Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Spectralis FAF imaging, Optos imaging and Clarus imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
- Participants that are willing to participate as evidenced by signing the written informed consent
Who cannot join
- Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
- Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
- Patients with advanced IRDs who are unable to fixate for imaging
- Patients unable to tolerate ocular imaging
- Patients who do not wish to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, 53705
Amy Remm, 608-262-3377, amy.remm@wisc.edu
Kimberly Stepien, MD
About this study
The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).
Participants will:
- undergo pupillary dilation
- have photographs taken of the inside of the eyes using three different cameras
- Conditions
- Retinal Disease
- Being tested
- Spectralis FAF imaging, Optos imaging, Clarus imaging
- Medical subject headings
- Retinal Diseases
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.
Clarus imagingDevice
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: Clarus imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Measured: Up to 2 hours
Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Measured: Up to 2 hours
Compare FAF retinal patterns by Clarus and Optos FAF imaging
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Measured: Up to 2 hours
Compare Spectralis FAF imaging to Spectralis OCT imaging
In participants with clearly defined macular FAF retinal pattern changes, graders will independently measure area of retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Measured: Up to 2 hours
Secondary outcomes (2)
Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images
The presence of FAF retinal pattern changes outside field 2 will be documented from the two ultrawide field imaging devices
Measured: Up to 2 hours
Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging
The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start29 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Stepien, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380075
- Sponsor's protocol ID
- 2024-0480
- Other IDs
- A536000, SMPH/OPHTHAL&VIS SCI/GEN, Protocol Version 3/11/25
- Acronym
- COCO-IRD
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- 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 23 Oct 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 Inherited Retinal Disease
- ClinicalTrials.gov ID
- NCT06380075
- Acronym / sponsor ID
- COCO-IRD / 2024-0480
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
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 research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).
Participants will:
- undergo pupillary dilation
- have photographs taken of the inside of the eyes using three different cameras
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: Clarus imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
- Participants that are willing to participate as evidenced by signing the written informed consent
Key exclusion criteria (5 listed)
- Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
- Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
- Patients with advanced IRDs who are unable to fixate for imaging
- Patients unable to tolerate ocular imaging
- Patients who do not wish to participate
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 |
| Clarus imagingClarus 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
Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging
Time frame: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging
Time frame: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare FAF retinal patterns by Clarus and Optos FAF imaging
Time frame: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare Spectralis FAF imaging to Spectralis OCT imaging
Time frame: Up to 2 hours
In participants with clearly defined macular FAF retinal pattern changes, graders will independently measure area of retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
2 secondary outcomes
Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images
Time frame: Up to 2 hours
Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging
Time frame: Up to 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- 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.
Kimberly Stepien, MD 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 Clarus imaging in people with Retinal Disease, 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angie Adler (608-265-7557, amadler1@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging (time frame: Up to 2 hours). The study lists 4 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 23 Oct 2026.