Retinal Disease
Conditions
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
Interventions
DEVICESpectralis 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.
DEVICEOptos 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.
DEVICEClarus 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
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAngie Adler
PRINCIPAL_INVESTIGATORKimberly Stepien, MD
University of Wisconsin, Madison
Outcome results
None listed