COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease (COCO-IRD)

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 Overview

• Status: Recruiting
• Conditions: Retinal Disease
• Intervention / Treatment: Device: Spectralis FAF imaging; Device: Optos imaging; Device: Clarus imaging

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angie Adler; Phone Number: 608-265-7557; Email: amadler1@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • Department of Ophthalmology and Visual Sciences
      • Contact: Amy Remm; Phone Number: 608-262-3377; Email: amy.remm@wisc.edu
      • Principal Investigator: Kimberly Stepien, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fundus autofluorescence (FAF) imaging

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 2 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Kimberly Stepien, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: 2024-0480; A536000 (Other Identifier: UW Madison); SMPH/OPHTHAL&VIS SCI/GEN (Other Identifier: UW Madison); Protocol Version 3/11/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No