Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Positive predictive value (PPV) as measured by OCT images.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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/
- •7. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.
研究组 & 干预措施
Technician-acquired OCT
Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care.
干预措施: Technician-acquired OCT imaging (Procedure)
Self-administered OCT Images
Participants will use an OCT device to obtain OCT images of the eyes.
干预措施: Self-administered OCT imaging system (Procedure)
结局指标
主要结局
Positive predictive value (PPV) as measured by OCT images.
时间窗: through study completion, an average of 1 year
Negative predictive value (NPV) as measured by OCT images.
时间窗: through study completion, an average of 1 year
Number of inner retinal abnormalities detected as measured by OCT images
时间窗: through study completion, an average of 1 year
Number of outer retinal abnormalities detected as measured by OCT images.
时间窗: through study completion, an average of 1 year
Sensitivity as measured by OCT images.
时间窗: through study completion, an average of 1 year
Specificity as measured by OCT images.
时间窗: through study completion, an average of 1 year
次要结局
- Image-quality as recorded by nurse coordinator during patient interaction with the device.(through study completion, an average of 1 year)
- Number of successful completion of self-scans as recorded by nurse coordinator during patient interaction with the device.(through study completion, an average of 1 year)
- Number of repeated attempts(through study completion, an average of 1 year)
研究者
Warren Sobol
Physician
Case Western Reserve University