Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Cataract Clinical Trial

Official title:

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390245
• Other study ID #: 14-441
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 2020

Study information

• Verified date: August 2022
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 906
• Est. completion date: August 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

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

Intervention

Other:
• Free Eye Screenings
This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.
• 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.
• Usual Care
This group will receive ophthalmic referral.

Locations

Country	Name	City	State
United States	Wills Eye Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Wills Eye	Centers for Disease Control and Prevention, Philadelphia Department of Public Health, Public Health Management Corporation, Temple Physicians, Inc., The Health Federation of Philadelphia, Westat

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundus Camera Images Via Telemedicine	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.	1 hour eye exam
Primary	Intraocular Pressure	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.	1 hour eye exam
Primary	Diagnostic Image Confirmation by Ophthalmologist	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.	1 hour eye examination
Secondary	Adherence to Follow-up Ophthalmic Care.	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.	5 year follow-up period.