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Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Primary Purpose

Glaucoma, Glaucoma Suspect, Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free Eye Screenings
Enhanced Intervention
Usual Care
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

-

Sites / Locations

  • Wills Eye Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1: Telemedicine Screening Participants

Phases 2 and 3: Enhanced Intervention Group

Phases 2 and 3: Usual Care Group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 11, 2015
Last Updated
August 19, 2022
Sponsor
Wills Eye
Collaborators
Centers for Disease Control and Prevention, Westat, Public Health Management Corporation, Philadelphia Department of Public Health, The Health Federation of Philadelphia, Temple Physicians, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02390245
Brief Title
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Official Title
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Centers for Disease Control and Prevention, Westat, Public Health Management Corporation, Philadelphia Department of Public Health, The Health Federation of Philadelphia, Temple Physicians, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
906 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Telemedicine Screening Participants
Arm Type
Experimental
Arm Description
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).
Arm Title
Phases 2 and 3: Enhanced Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Phases 2 and 3: Usual Care Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Free Eye Screenings
Intervention Description
This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.
Intervention Type
Other
Intervention Name(s)
Enhanced Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
This group will receive ophthalmic referral.
Primary Outcome Measure Information:
Title
Fundus Camera Images Via Telemedicine
Description
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.
Time Frame
1 hour eye exam
Title
Intraocular Pressure
Description
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.
Time Frame
1 hour eye exam
Title
Diagnostic Image Confirmation by Ophthalmologist
Description
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.
Time Frame
1 hour eye examination
Secondary Outcome Measure Information:
Title
Adherence to Follow-up Ophthalmic Care.
Description
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.
Time Frame
5 year follow-up period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. J Katz, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A Hark, PhD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia A Haller, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A methods paper with year-1 baseline data and cost analysis has been published. Additional scientific manuscripts are under development.
Citations:
PubMed Identifier
28673747
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.
Results Reference
result
PubMed Identifier
34014814
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.
Results Reference
result
PubMed Identifier
30770354
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.
Results Reference
derived

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Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

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