Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

NCT02390245 | Completed Results DMC

• 1 other identifier: 14-441
• Study Type: interventional
• Target: 906
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Adherence to Follow-up Ophthalmic Care.

  5 year follow-up period.

Study Arms (3)

Phase 1: Telemedicine Screening Participants

EXPERIMENTAL

Participants across the Philadelphia, PA region were invited to participate in free eye screenings at primary care physician offices or health centers. Screenings included images of optic nerve and macula using non-contact, autofocus, hand-held fundus cameras (Volk Optical, Mentor, Ohio, USA) and measuring Intraocular Pressure (IOP) in millimeters of mercury (mm Hg) with non-contact rebound tonometers TA01I (ICare, Helsinki, Finland).

Other: Free Eye Screenings

Phases 2 and 3: Enhanced Intervention Group

EXPERIMENTAL

From eye screening results (visit 1), Phase 2 includes participants requiring further evaluation received comprehensive eye exam to confirm diagnosis (visit 2). Following confirmation diagnosis, patients were randomized to the Enhanced Intervention Group and were referred to a general ophthalmologist for follow-up eye care. Patient navigation and a social worker and referred to a general ophthalmologist close to the current health center or primary care physician office where they received the non dilated eye exam. Prior to all follow-up visits, patients in the Enhanced Intervention Group were provided a scheduled appointment and received a personal phone call reminding them to attend. Patients received necessary interpretation services and educational materials. Phase 3. Includes following this group over a 5 year period for adherence to eye care.

Other: Enhanced Intervention

Phases 2 and 3: Usual Care Group

EXPERIMENTAL

From eye screening results (visit 1), Phase 2 includes participants requiring further evaluation received comprehensive eye exam to confirm diagnosis (visit 2). Following confirmation diagnosis, patients were randomized to the Usual Care Group and were referred to a general ophthalmologist for follow-up eye care. These patients were scheduled for their initial follow-up visit based on the recommendations of our study physicians so the research team was able to track outcomes. This group represents a realistic choice currently available for patients. Practice patterns vary depending on the resources, staff time, and services available within each local ophthalmology practice. Phase 3. Includes following this group over a 5 year period for adherence to eye care.

Other: Usual Care

Interventions

Free Eye Screenings OTHER

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

Phase 1: Telemedicine Screening Participants

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.

Phases 2 and 3: Enhanced Intervention Group

Usual Care OTHER

This group will receive ophthalmic referral.

Phases 2 and 3: Usual Care Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

• 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.

  PMID: 28673747 RESULT

• 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.

  PMID: 34014814 RESULT

• 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.

  PMID: 30770354 DERIVED

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Diabetic Retinopathy; Cataract; Retinal Vein Occlusion; Retinal Artery Occlusion; Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Lens Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Arterial Occlusive Diseases; Retinal Degeneration; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. L. Jay Katz
• Organization: Wills Eye Hospital

jmolineaux@willseye.org

215-825-4713

Study Officials

• L. J Katz, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

• Lisa A Hark, PhD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

• Julia A Haller, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: August 1, 2020
• Last Updated: August 22, 2022
• Results First Posted: March 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)