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

NCT ID: NCT06380075

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-29

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Retinal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fundus autofluorescence (FAF) imaging

Group Type EXPERIMENTAL

Spectralis FAF imaging

Intervention Type 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

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Stepien, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angie Adler

Role: CONTACT

Phone: 608-265-7557

Email: [email protected]

Facility Contacts

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Amy Remm

Role: primary

Other Identifiers

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A536000

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/OPHTHAL&VIS SCI/GEN

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/22/24

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0480

Identifier Type: -

Identifier Source: org_study_id