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Completed

NCT Number: NCT02390245

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

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.

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Key information

Conditions

Glaucoma Arterial Occlusive Diseases Branch Retinal Arterial Occlusion Branch Retinal Vein Occlusion Cardiovascular Diseases Cataract Central Retinal Artery Occlusion Central Retinal Vein Occlusion Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Drusen Embolism and Thrombosis Endocrine System Diseases Epi-retinal Membrane Eye Diseases Glaucoma Suspect Lens Diseases Loss of Vision Macular Degeneration Nervous System Diseases Neurologic Manifestations Ocular Hypertension Pathological Conditions, Signs and Symptoms Retinal Artery Occlusion Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Sensation Disorders Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis Vision Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

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Treatment and study plan

Free Eye Screenings

Other

This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.

Enhanced Intervention

Other

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.

Usual Care

Other

This group will receive ophthalmic referral.

Primary outcomes

  1. Fundus Camera Images Via Telemedicine

    Time frame: 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.

  2. Intraocular Pressure

    Time frame: 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.

  3. Diagnostic Image Confirmation by Ophthalmologist

    Time frame: 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.

Secondary outcomes

  1. Adherence to Follow-up Ophthalmic Care.

    Time frame: 5 year follow-up period.

    Phase III: Compliance by participants was monitored for attending recommended follow-up eye care with ophthalmologist/optometrist in the Usual Care and Intervention Groups during a 5 year period. Follow-up visit recommendations were not predetermined, they were at the ophthalmologist/optometrist discretion and /or according to clinical practice. Adherence was achieved when completing visit 3 within 12 months of randomization. Visit 4 adherence was achieved if recommended follow-up of 3-4 months, 6 months or 12 months were completed within 6, 12 or 15 months, respectively.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Health Federation of Philadelphia
  • Philadelphia Department of Public Health
  • Public Health Management Corporation
  • Temple Physicians, Inc.
  • Westat

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Mar 17, 2015
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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