NCT06380075 · University of Wisconsin, Madison
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
(COCO-IRD)
What this study is about
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).
View original scientific description
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).
Interventions
DEVICE
Spectralis FAF imaging
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.
DEVICE
Optos imaging
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.
DEVICE
Clarus imaging
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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations