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临床试验/NCT02390245
NCT02390245已完成不适用

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Wills Eye2 个研究点 分布在 1 个国家目标入组 906 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
906
试验地点
2
主要终点
Fundus Camera Images Via Telemedicine

研究概览

简要总结

The goal is to conduct a 5-year prospective, randomized controlled trial to test an innovative, community-based intervention using posterior and anterior fundus photography of the optic nerve and macula and intraocular eye pressure measurements to improve access and utilization of eye care to detect, treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye diseases. Research shows that subject failure to attend follow-up eye care appointments diminishes any previous benefits of community screenings for glaucoma. Greater adherence to follow-up visits can reduce glaucomatous blindness.

详细描述

The project will be divided into following parts:

  • Phase 1 will consist of recruiting patients from primary care offices and federally qualified health centers across Philadelphia and Chester counties. Using fundus photography of optic nerve and macula via telemedicine and measurement of intraocular pressure, eye disease will be detected at Visit 1, followed by a comprehensive eye exam by a glaucoma specialist in the primary care setting to confirm the diagnosis (Visit 2) of qualifying participants requiring further evaluation. Predictive accuracy of optic nerve images to detect glaucoma, glaucoma suspect and other eye diseases as confirmed by the comprehensive eye exam will be evaluated.
  • Phase 2 will involve consenting, enrolling, and randomizing the qualifying participants confirmed by diagnosis at Visit 2 to either the Usual Care group or the Enhanced Intervention group and scheduling follow-up eye exams with a local, general ophthalmologist in an office-based setting (Visit 3). Enhanced intervention will use patient navigators and a social worker to reduce barriers to follow-up eye care.
  • Phase 3 will involve monitoring the randomized participants attendance of proximal (1-2 months) and distal (3 years) follow-up care appointments (Visits 3-8) with a local ophthalmologist. Adherence to recommendations for follow-up eye care will be the primary outcome measure. A comprehensive estimation of intervention costs and cost-effectiveness of detecting eye diseases and vision impairment in a high-risk population will also be conducted. Protocols, materials, and results will be disseminated to other organizations, stakeholders and communities in order to expand detection of glaucoma, other eye diseases, and visual impairment, and to further refine these approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • African-American, Hispanic, or Asian individuals over age 40
  • Caucasian individuals over age 65
  • Individuals of any ethnicity, over age 40 with a family history of glaucoma
  • Individuals of any ethnicity, over age 40 with diabetes
  • Individuals who meet one of the above criteria who have not seen an ophthalmologist in the past year

排除标准

  • Any patient with previously diagnosed glaucoma, glaucoma suspect, or eye diseases who is currently being followed by an ophthalmologist

结局指标

主要结局

Fundus Camera Images Via Telemedicine

时间窗: 1 hour eye exam

Phase I. Detection of glaucoma and other eye diseases using non contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) with images of optic nerve and macula and confirmed at follow-up full dilated eye examination by ophthalmologists.

Intraocular Pressure

时间窗: 1 hour eye exam

Phase I. Intraocular pressure (IOP) as measured in millimeters of mercury (mm Hg) with non contact rebound tonometer TA01I (ICare, Helsinki, Finland). Single IOP taken for each eye. If IOP \> 22 mm Hg, a second IOP was taken of that eye. If difference between 2 measurements \< 2 mm Hg, average was recorded. If difference between 2 measurements \> 2 mm Hg, a third measurement was obtained, and median was recorded. If final IOP \> 30 mm Hg, participant was Fast Tracked to Visit 2.

Diagnostic Image Confirmation by Ophthalmologist

时间窗: 1 hour eye examination

Phase I. Confirmation of telemedicine screen Visit 1 findings with a diagnosis following complete dilated eye examination and visual field by study team and Ophthalmologist at Visit 2.

次要结局

  • Adherence to Follow-up Ophthalmic Care.(5 year follow-up period.)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

L. Jay Katz MD

MD

Wills Eye

研究点 (2)

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