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临床试验/NCT03343730
NCT03343730Unknown不适用

Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic

Bassett Healthcare2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Rate of Diabetic Retinopathy Detection

研究概览

简要总结

the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.

详细描述

The Centers for Disease Control and Prevention (CDC) have estimated that 25.6 million Americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. As such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (DR). Of those Type 2 patients with a known duration of diabetes of less than 5 years, DR was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. These percentages are especially concerning since data presented by Schoenfeld and colleagues indicates that approximately 35% of Americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their DR.10 Reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. In addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. Per the American Diabetes Association (ADA) guidelines, it is recommended that all Type 2 patients receive annual dilated eye exams. These eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). Early detection of DR and the preventative effects of therapy is an important aspect for long term vision outcomes.

The long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. It is hypothesized that in type II diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of DR.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Type II diabetes without documented diabetic retinopathy

排除标准

  • Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
  • Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
  • Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
  • Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
  • Seen within the last 11 months for a diabetic eye exam.

研究组 & 干预措施

Non-mydriatic color fundus photography

Experimental

All participants will receive Non-mydriatic color fundus photography with the RetinaVue camera at an already scheduled annual physical exam or follow up clinic visit with their primary care provider (PCP).

干预措施: Non-mydriatic color fundus photography with the RetinaVue camera (Diagnostic Test)

Standard of Care (Control)

Active Comparator

All patients will also receive a referral for a dilated eye exam with an eye care professional. A yearly dilated exam as referred by the PCP.

干预措施: Referral for dilated eye exam with an eye care professional (Diagnostic Test)

结局指标

主要结局

Rate of Diabetic Retinopathy Detection

时间窗: 3 months

This study will examine the rate of detection of diabetic retinopathy using an in-clinic retinal camera and standard referral to eye care professional for dilated eye exam

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Dalton

Attending Physician - Primary Care

Bassett Healthcare

研究点 (2)

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