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

Retinal Disease Clinical Trial

— COCO-IRD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380075
• Other study ID #: 2024-0480
• Secondary ID: A536000SMPH/OPHT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Amy Remm
• Phone: 608-262-3377
• Email: amy.remm[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Department of Ophthalmology and Visual Sciences	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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