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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Fundus autofluorescence (FAF) imagingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 hours
2

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.

Time frame
Up to 2 hours
3

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.

Time frame
Up to 2 hours
4

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.

Time frame
Up to 2 hours

Secondary outcomes

1

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

Time frame
Up to 2 hours
2

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

Time frame
Up to 2 hours

Other outcomes

Sponsors and contacts

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