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NCT Number: NCT06380075

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

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

Recruiting

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Amy Remm

CONTACT

[email protected]

608-262-3377

Kimberly Stepien, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

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

    Time frame: Up to 2 hours

    The presence of FAF retinal pattern changes outside field 2 will be documented from the two ultrawide field imaging devices

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

    Time frame: Up to 2 hours

    The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices

Study contacts

Contact information is provided by the study sponsor or research team.

Angie Adler

CONTACT

[email protected]

608-265-7557

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Acronym: COCO-IRD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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