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

Обзор

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

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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

Первичные конечные точки

• Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging [Срок оценки: Up to 2 hours]
• Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging [Срок оценки: Up to 2 hours]
• Compare FAF retinal patterns by Clarus and Optos FAF imaging [Срок оценки: Up to 2 hours]
• Compare Spectralis FAF imaging to Spectralis OCT imaging [Срок оценки: Up to 2 hours]

Вторичные конечные точки (2)

• Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images [Срок оценки: Up to 2 hours]
• Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging [Срок оценки: Up to 2 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Department of Ophthalmology and Visual Sciences — Madison

Идентификаторы

NCT: NCT06380075 · 2024-0480 · A536000 · SMPH/OPHTHAL&VIS SCI/GEN · Protocol Version 3/11/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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