Clinical trial NCT02390245: Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Official title: Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Westat
name: Public Health Management Corporation
name: Philadelphia Department of Public Health
name: Health Federation of Philadelphia
name: Temple Physicians, Inc.
First posted: 2015-03-17
Enrollment: 906
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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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Primary outcomes:
measure: Fundus Camera Images Via Telemedicine
timeFrame: 1 hour eye exam
measure: Intraocular Pressure
timeFrame: 1 hour eye exam
measure: Diagnostic Image Confirmation by Ophthalmologist
timeFrame: 1 hour eye examination
Secondary outcomes:
measure: Adherence to Follow-up Ophthalmic Care.
timeFrame: 5 year follow-up period.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: L. J Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wills Eye Hospital
name: Lisa A Hark, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wills Eye Hospital
name: Julia A Haller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hark LA, Katz LJ, Myers JS, Waisbourd M, Johnson D, Pizzi LT, Leiby BE, Fudemberg SJ, Mantravadi AV, Henderer JD, Zhan T, Molineaux J, Doyle V, Divers M, Burns C, Murchison AP, Reber S, Resende A, Bui TDV, Lee J, Crews JE, Saaddine JB, Lee PP, Pasquale LR, Haller JA. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Methods and Screening Results. Am J Ophthalmol. 2017 Sep;181:114-124. doi: 10.1016/j.ajo.2017.06.024. Epub 2017 Jun 30.
citation: Leiby BE, Hegarty SE, Zhan T, Myers JS, Katz LJ, Haller JA, Waisbourd M, Burns C, Divers M, Molineaux J, Henderer J, Brodowski C, Hark LA. A Randomized Trial to Improve Adherence to Follow-up Eye Examinations Among People With Glaucoma. Prev Chronic Dis. 2021 May 20;18:E52. doi: 10.5888/pcd18.200567.
citation: Hark LA, Myers JS, Ines A, Jiang A, Rahmatnejad K, Zhan T, Leiby BE, Hegarty S, Fudemberg SJ, Mantravadi AV, Waisbourd M, Henderer JD, Burns C, Divers M, Molineaux J, Pizzi LT, Murchison AP, Saaddine J, Pasquale LR, Haller JA, Katz LJ. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: confirmation between eye screening and comprehensive eye examination diagnoses. Br J Ophthalmol. 2019 Dec;103(12):1820-1826. doi: 10.1136/bjophthalmol-2018-313451. Epub 2019 Feb 15.