COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease

NCT06380075 | Recruiting DMC FDA Device

• 4 other identifiers: 2024-0480A536000SMPH/OPHTHAL&VIS SCI/GENProtocol Version 3/11/25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). Participants will:

• undergo pupillary dilation
• have photographs taken of the inside of the eyes using three different cameras

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images

  Up to 2 hours

• Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging

  Up to 2 hours

Study Arms (1)

Fundus autofluorescence (FAF) imaging

EXPERIMENTAL

Device: Spectralis FAF imaging; Device: Optos imaging; Device: Clarus imaging

Interventions

Spectralis FAF imaging DEVICE

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.

Fundus autofluorescence (FAF) imaging

Optos imaging DEVICE

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.

Fundus autofluorescence (FAF) imaging

Clarus imaging DEVICE

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

Fundus autofluorescence (FAF) imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Kimberly Stepien, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Adler

CONTACT

608-265-7557; amadler1@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)