COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
- Conditions
- Retinal Disease
- Interventions
- Device: Spectralis FAF imagingDevice: Optos imagingDevice: Clarus imaging
- Registration Number
- NCT06380075
- Lead Sponsor
- University of Wisconsin, Madison
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fundus autofluorescence (FAF) imaging Spectralis FAF imaging - Fundus autofluorescence (FAF) imaging Optos imaging - Fundus autofluorescence (FAF) imaging Clarus imaging -
- Primary Outcome Measures
Name Time Method Compare FAF retinal patterns by Clarus and Optos FAF imaging 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.
Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging 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.
Compare Spectralis FAF imaging to Spectralis OCT imaging 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.
Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging 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.
- Secondary Outcome Measures
Name Time Method Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images Up to 2 hours The presence of FAF retinal pattern changes outside field 2 will be documented from the two ultrawide field imaging devices
Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging Up to 2 hours The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Trial Locations
- Locations (1)
Department of Ophthalmology and Visual Sciences
🇺🇸Madison, Wisconsin, United States