NCT02390245

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 906 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma
• Glaucoma Suspect
• Diabetic Retinopathy
• Ocular Hypertension
• Cataract
• Branch Retinal Vein Occlusion
• Branch Retinal Arterial Occlusion
• Central Retinal Vein Occlusion
• Central Retinal Artery Occlusion
• Epi-retinal Membrane
• Macular Degeneration
• Drusen
• Loss of Vision

Interventions

Type	Name	Description
OTHER	Free Eye Screenings	This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.
OTHER	Enhanced Intervention	This group will receive ophthalmic referral and a navigator for assistance in scheduling appointments; confirming appointments via phone, mail, email and/or text message; arranging transportation through Customized Community Transportation (CCT) and Philadelphia Paratransit Service; and trained medical interpreters as needed.
OTHER	Usual Care	This group will receive ophthalmic referral.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-09-01
• Completion: 2020-08-01
• First posted: 2015-03-17
• Last updated: 2022-08-22
• Results posted: 2022-03-11

Locations

1 site across 1 country: United States