Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Not Applicable

Completed

• Conditions: Diabetic Retinopathy; Ocular Hypertension; Branch Retinal Arterial Occlusion; Central Retinal Vein Occlusion; Loss of Vision; Glaucoma Suspect; Cataract; Branch Retinal Vein Occlusion; Epi-retinal Membrane; Drusen

• Registration Number: NCT02390245
• Lead Sponsor: Wills Eye

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Primary Completion: 2019-09
• Study Completion: 2020-08
• Results First Submitted: 2020-10-30
• Results First Submitted QC: 2021-12-20
• Results First Posted: 2022-03-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 906

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fundus Camera Images Via Telemedicine	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	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	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 Outcome Measures

Name	Time	Method
Adherence to Follow-up Ophthalmic Care.	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.

Trial Locations

Locations (1)

Wills Eye Glaucoma Service; 🇺🇸 Philadelphia, Pennsylvania, United States