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Идёт набор NCT03713268

Intraoperative OCT Guidance of Intraocular Surgery II

— Наблюдательное Macular Holes Epiretinal Membrane Diabetic Retinopathy Retinal Detachment

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: Microscope integrated optical coherence tomography.
Кому может быть актуально
Состояния в реестре: Macular Holes, Epiretinal Membrane, Diabetic Retinopathy, Retinal Detachment. Базовые параметры: от 4 Weeks · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Intraoperative OCT Guidance of Intraocular Surger

Обзор

The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.

Вмешательства

  • Устройство Microscope integrated optical coherence tomography
    This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visi

Первичные конечные точки

  • Retinal and/or corneal microscope integrated optical coherence tomography image capture [Срок оценки: Year 1]
  • Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture [Срок оценки: Year 1]
  • Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography [Срок оценки: Year 1]
  • Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps. [Срок оценки: Year 1]
  • Assessment of change in ocular morphology before and after standard surgical steps [Срок оценки: Year 1]
  • Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output [Срок оценки: Year 1]

Критерии участия

Критерии включения

  • Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.
  • Surgeons as research subjects: Adult (≥18 years old)
  • Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases
  • Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.

Критерии исключения

  • Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator.
  • Surgeons as research subjects: no specific exclusion criteria.
  • Surgical patients (vitreoretinal surgery): Neonates (< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.
  • Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Duke University Eye Center — Durham

Идентификаторы

NCT: NCT03713268 · Pro00100437 · U01EY028079

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗