Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
300

Summary

Conditions
  • Branch Retinal Arterial Occlusion
  • Branch Retinal Vein Occlusion
  • Cataract
  • Central Retinal Artery Occlusion
  • Central Retinal Vein Occlusion
  • Diabetic Retinopathy
  • Drusen
  • Epi-retinal Membrane
  • Ocular Hypertension
  • Glaucoma
  • Glaucoma Suspect
  • Macular Degeneration
  • Loss of Vision
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Other

Participation Requirements

Age
Between 40 years and 125 years
Gender
Both males and females

Description

The project will be divided into following parts: Phase 1 will consist of recruiting approximately 900 patients from primary care offices and federally qualified health centers across Philadelphia and Chester counties. Using telemedicine, we will detect eye disease at Visit 1, followed by a comprehe...

The project will be divided into following parts: Phase 1 will consist of recruiting approximately 900 patients from primary care offices and federally qualified health centers across Philadelphia and Chester counties. Using telemedicine, we will detect eye disease at Visit 1, followed by a comprehensive eye exam by a glaucoma specialist in the primary care setting to confirm the diagnosis (Visit 2). Based on preliminary data, 50% of patients will have abnormal optic nerve and/or macular images. The predictive accuracy of the 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 343 patients to either the usual care group (n=171) or the enhanced intervention group (n=172) and scheduling follow-up eye exams with a local, general ophthalmologist in an office-based setting (Visit 3). The enhanced intervention will consist of using patient navigators and a social worker to reduce barriers to follow-up eye care. Phase 3 will involve following patients for proximal (1-2 months) and distal (3 years) follow-up care appointments (Visits 3-8) with a local ophthalmologist. Adherence to follow-up recommendations for eye care will be the primary outcome measure. A comprehensive cost study to estimate the 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.

Tracking Information

NCT #
NCT02390245
Collaborators
  • Centers for Disease Control and Prevention
  • Westat
  • Public Health Management Corporation
  • Philadelphia Department of Public Health
  • The Health Federation of Philadelphia
  • Temple Physicians, Inc.
Investigators
Principal Investigator: L. J Katz, MD Wills Eye Hospital Principal Investigator: Lisa A Hark, PhD Wills Eye Hospital Principal Investigator: Julia A Haller, MD Wills Eye Hospital