Self-Monitoring OCT

Официальное название

Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth

Обзор

The purpose of this research study is to test participants ability to obtain OCT images of the eyes using an OCT device that is comparable to FDA-approved OCT devices on the market, without the help of an eye technician. Patients with ocular diseases often need to come to frequent appointments with an eye care provider for close monitoring and evaluation. Transportation difficulties, other medical problems, and limited appointments slots can make regular follow-up challenging. In addition, the anxiety of permanent vision loss and subjective nature of monitoring symptoms highlight the need for an alternative solution in which patients can self-generate OCT images of the eye for the eye care provider to review.

Вмешательства

• Процедура Self-administered OCT imaging system
  Self-administered OCT imaging using modified portable OCT with headrest and software workflow to enable patient self-operation and secure image transfer to a remote reading center.
• Процедура Technician-acquired OCT imaging
  Technician-acquired OCT obtained using routine clinical equipment during the same visit

Первичные конечные точки

• Number of inner retinal abnormalities detected as measured by OCT images [Срок оценки: Up to 60 minutes]
• Number of outer retinal abnormalities detected as measured by OCT images. [Срок оценки: Up to 60 minutes]
• Sensitivity as measured by OCT images. [Срок оценки: Up to 60 mins]
• Specificity as measured by OCT images. [Срок оценки: Up to 60 mins]
• Positive predictive value (PPV) as measured by OCT images. [Срок оценки: Up to 60 mins]
• Negative predictive value (NPV) as measured by OCT images. [Срок оценки: Up to 60 mins]

Вторичные конечные точки (3)

• Image-quality as recorded by nurse coordinator during patient interaction with the device. [Срок оценки: Up to 60 mins]
• Number of successful completion of self-scans as recorded by nurse coordinator during patient interaction with the device. [Срок оценки: Up to 60 mins]
• Number of repeated attempts [Срок оценки: Up to 60 mins]

Критерии участия

Критерии включения

• 1\. Provision of signed and dated informed consent.
• 2\. Age ≥ 18 years.
• 3\. Presenting for care at a University Hospitals Eye Institute clinic
• 4\. Willing to complete study questionnaires.
• 5\. Scheduled to undergo standard technician-acquired OCT

Критерии исключения

• 1\. Unable to provide informed consent or, in the judgment of study staff, unable to understand study procedures.
• 2\. Unable to cooperate with imaging or maintain stable positioning such that an evaluable OCT scan cannot be obtained (e.g., severe tremor or inability to maintain head position).
• 3\. Facial skin condition or open wound at the points of device contact that would make use of the headrest unsafe.
• 4\. Acute medical or ocular condition requiring immediate evaluation that, in the PI's judgment, precludes participation at that time.
• 5\. Any other condition that, in the opinion of the PI/designee, would place the participant at undue risk or compromise data quality (documented).
• 6\. Patients with visual acuity <20/200.
• 7\. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07584798 · STUDY20211004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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