COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spectralis FAF imaging, Optos imaging, Clarus imaging.
- Who it may be relevant to
- Registry conditions: Retinal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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. - 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. - 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
Primary outcome measures
- Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging [Time frame: Up to 2 hours]
- Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging [Time frame: Up to 2 hours]
- Compare FAF retinal patterns by Clarus and Optos FAF imaging [Time frame: Up to 2 hours]
- Compare Spectralis FAF imaging to Spectralis OCT imaging [Time frame: Up to 2 hours]
Secondary outcome measures (2)
- Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images [Time frame: Up to 2 hours]
- Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging [Time frame: Up to 2 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Department of Ophthalmology and Visual Sciences — Madison
Identifiers
NCT: NCT06380075 · 2024-0480 · A536000 · SMPH/OPHTHAL&VIS SCI/GEN · Protocol Version 3/11/25