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Идёт набор NCT07555574

Defining Retinal Structures Using Hyperspectral Retinal Imaging

Без фазы С лечением Age-Related Macular Degeneration Diabetic Retinopathy Glaucoma Retinal Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hyperspectral camera.
Кому может быть актуально
Состояния в реестре: Age-Related Macular Degeneration, Diabetic Retinopathy, Glaucoma, Retinal Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австралия
Следующий шаг
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Обзор

This study evaluates hyperspectral retinal imaging as a novel, non-invasive imaging technique to characterise retinal and optic nerve structures in healthy individuals and patients with eye disease. Hyperspectral imaging captures retinal data across multiple wavelengths to generate detailed spectral information that may reveal features not visible with conventional retinal photography. Approximately 1000 participants will undergo multi-modal ophthalmic imaging in Melbourne, Australia, including hyperspectral imaging, OCT, fundus photography, and related tests. The study aims to compare hyperspectral imaging with standard imaging methods and assess its ability to identify retinal biomarkers associated with diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration.

Подробное описание

This is a investigator-initiated imaging study assessing hyperspectral retinal imaging (HSI) for characterising retinal and optic nerve structures in healthy and diseased eyes.

HSI acquires retinal images across multiple wavelengths (\>25 bands), producing a spectral "hypercube" containing spatial and spectral information for each pixel. This provides more detailed tissue information than conventional colour fundus photography.

Approximately 1000 participants will be recruited from ophthalmology clinics in Melbourne. All participants will undergo standard ophthalmic assessment and hyperspectral retinal imaging using the Optina device and a CERA prototype camera.

Hyperspectral images will be processed with registration and spectral normalisation to extract pixel-level reflectance signatures. These data will be analysed using statistical and machine learning methods and compared with established imaging biomarkers to evaluate their ability to distinguish disease states.

Вмешательства

  • Устройство Hyperspectral camera
    Hyperspectral imaging is performed with the Metabolic Hyperspectral Retinal Camera (Optina Diagnostic, Montreal, Canada) and a prototype camera developed by researchers at the Centre for Eye Research Australia (CERA). The Metabolic Hyperspectral Retinal Camera is similar to a typical fundus imager but it incorporates a tunable light source which is able to transmit safe light levels within a wavelength range covering the visible to near infrared with a narrow bandwidth (\< 3nm). This instrument

Первичные конечные точки

  • Diagnostic performance of hyperspectral imaging-derived spectral score for detection of retinal disease [Срок оценки: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition]

Критерии участия

Критерии включения

  • Adults aged 18 years and older
  • Able to provide informed consent
  • Willing and able to attend a study visit at the Centre for Eye Research Australia
  • Participants with diagnosed retinal or optic nerve disease (e.g., diabetic retinopathy, glaucoma, age-related macular degeneration)
  • Age- and sex-matched healthy control participants without known retinal or optic nerve disease

Критерии исключения

  • Inability to provide informed consent
  • Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)
  • Known contraindication to pharmacological pupil dilation
  • History of narrow anterior chamber angle or risk of angle closure glaucoma where dilation is considered unsafe
  • Any condition that, in the investigator's opinion, would compromise participant safety or image quality

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Австралия · 1 центр
  • The Centre for Eye Research Australia — Melbourne

Идентификаторы

NCT: NCT07555574 · 167/21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗