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Идёт набор NCT00286637

Novel Glaucoma Diagnostics

Наблюдательное Glaucoma Macular Disease

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Glaucoma, Macular Disease. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Novel Diagnostics for Ocular Structure

Обзор

The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases

Подробное описание

Objective:

The purpose of this research is to evaluate a new technology, optical coherence tomography (OCT), to image diseases of the eye and to compare the measurements obtained using OCT with those of other imaging and visual field devices. OCT may be useful for the early diagnosis and monitoring of a variety of eye diseases such as age-related macular degeneration (ARMD), glaucoma, diabetic retinopathy, macular edema, and other pathologies.

Specific Aims:

There are four sub-studies: cross-sectional, longitudinal, reproducibility, and an Alzheimer's Disease (AD) sub-study. The cross-sectional and longitudinal arms study the effectiveness of the OCT technology in terms of detecting and monitoring eye diseases. The reproducibility study is designed to test the measurement likeness of the OCT. The AD sub-study will use high resolution ocular imaging technologies to determine ocular biomarkers for sensitive detection of AD.

Background:

This is a continuation of an ongoing study from the New England Eye Center (NEEC), Tufts Medical Center, Boston, MA. This study started when our research group was located at NEEC and in collaboration with the Massachusetts Institute of Technology (MIT) where we conducted the first clinical studies with OCT. The first investigation using OCT was published in Science in 1991 and showed in vitro imaging of the human retina and atherosclerotic plaque. We developed an OCT prototype system for performing preliminary ophthalmic clinical studies and in 1993, began clinical OCT imaging studies.

The prototype ophthalmic OCT instrument acquired OCT images of the retina with an axial resolution of 10µm within an acquisition time of 2.5 sec. The OCT imaging system was integrated with a slit-lamp biomicroscope for in vivo tomography of the anterior and posterior eye. The beam is directed into the eye using computer controlled galvonometric scanners, which can scan arbitrary transverse patterns. The beam focus is coincident with the slit-lamp image plane to permit simultaneous scanning and visualization of the eye through the slit-lamp or via a CCD camera. For tomography of the anterior eye, the microscope is focused directly on the structure, while for retinal imaging, a lens relay images of the retina onto the slit-lamp image plane. A computer provides real-time display of the tomogram, image processing, and data management.

OCT technology was patented and subsequently transferred to industry (Zeiss Humphrey Systems, CA). Our prototype ophthalmic OCT system was developed into a clinical instrument and was introduced into the ophthalmic market in 1996. The commercial OCT technology has an axial resolution of 10 µm and can acquire a 100 transverse pixel retinal tomogram in 1 second. A third generation ophthalmic OCT imaging device, OCT3, was introduced three years ago. OCT imaging is now used as a standard diagnostic procedure as part of an ophthalmic examination for many retina and glaucoma patients at the University of Pittsburgh Medical Center (UPMC) Eye Center and New England Eye Center (NEEC). OCT imaging is in use in major research and clinical centers internationally. The OCT has been approved by the Food and Drug Administration for use in ophthalmology.

Significance:

OCT enables tissue pathology to be imaged in situ and in real time with a resolution approaching that of conventional histopathology but without the need for excising and processing specimens. OCT provides a quantitative method of directly measuring ocular structures with high precision and could provide an objective, early diagnosis for glaucoma, age related macular degeneration (ARMD), diabetic retinopathy, macular edema, and other pathologies. Extensive studies have been performed with OCT in cross-sectional as well as longitudinal setting. In this ongoing protocol, our objective is to continue these studies using the commercial ophthalmic OCT imaging instruments to develop methods for early detection and improve longitudinal assessment for the above mentioned ocular pathologies.

Первичные конечные точки

  • Number of Participants who Show Evidence of Glaucoma Progression [Срок оценки: Up to Year 5]

Критерии участия

Критерии включения

  • Ability to provide informed consent and to understand the study procedures
  • Healthy volunteers
  • Age related macular degeneration (AMD), diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects
  • (AD Sub-Study ONLY): Subjects diagnosed with AD or MCI.

Критерии исключения

  • Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
  • Strabismus, nystagmus, or any condition that prevents fixation.
  • Presence of any media opacities that hinders clinical view of the fundus, and any intraocular non-glaucomatous abnormality
  • History of ocular trauma or intraocular surgery other than uncomplicated glaucoma interventions or cataract extraction at least 3 months previous to participating in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Wills Eye Hospital — Philadelphia

Публикации

  • Mumcuoglu T, Townsend KA, Wollstein G, Ishikawa H, Bilonick RA, Sung KR, Kagemann L, Schuman JS; Advanced Imaging in Glaucoma Study Group. Assessing the relationship between central corneal thickness and retinal nerve fiber layer thickness in healthy subjects. Am J Ophthalmol. 2008 Oct;146(4):561-6. doi: 10.1016/j.ajo.2008.05.038. Epub 2008 Jul 26. PMID 18657796
  • Gabriele ML, Ishikawa H, Wollstein G, Bilonick RA, Townsend KA, Kagemann L, Wojtkowski M, Srinivasan VJ, Fujimoto JG, Duker JS, Schuman JS. Optical coherence tomography scan circle location and mean retinal nerve fiber layer measurement variability. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2315-21. doi: 10.1167/iovs.07-0873. PMID 18515577

Идентификаторы

NCT: NCT00286637 · 2023-37 - R01EY013178 · R01EY013178

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗