Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Sponsor
Wills Eye (Other)
Overall Status
Completed
CT.gov ID
NCT02390245
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), Westat (Other), Public Health Management Corporation (Other), Philadelphia Department of Public Health (U.S. Fed), The Health Federation of Philadelphia (Other), Temple Physicians, Inc. (Industry)
906
Enrollment
1
Location
3
Arms
71
Actual Duration (Months)
12.8
Patients Per Site Per Month

Study Details

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
906 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Phase 1: Telemedicine Screening Participants

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

Experimental: Phases 2 and 3: Enhanced Intervention Group

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
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.

Experimental: Phases 2 and 3: Usual Care Group

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
This group will receive ophthalmic referral.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

-

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wills Eye Glaucoma ServicePhiladelphiaPennsylvaniaUnited States19107

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
L. Jay Katz MD, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT02390245
Other Study ID Numbers:
  • 14-441
First Posted:
Mar 17, 2015
Last Update Posted:
Mar 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleTelemedicine Screening Participants - Phase 1Enhanced Intervention Group - Phases 2/3Usual Care Group - Phases 2/3
Arm/Group DescriptionPhase I Participants recruited from diverse underserved locations across the Philadelphia region were invited for a free eye screening Visit 1 conducted at 14 locations by study team. Screenings consisted of noncontact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) to detect abnormalities on optic nerve and macula. Trained ocular technicians captured 2 posterior and 1 anterior images per eye (6 photographs). Intraocular pressure (IOP) in millimeters of mercury (mm Hg) was assessed with noncontact rebound tonometer TA01I (ICare, Helsinki, Finland). Single IOP taken for each eye. If IOP > 22 mm Hg, second IOP taken of that eye. If difference between 2 measurements < 2 mm Hg, average recorded. If difference between 2 measurements > 2 mm Hg, third measurement obtained, and median recorded. Visual acuity measured with correction, if patient had glasses or contact lenses, using digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA). Medical, family and ocular history recorded. Participants with suspicious findings, high eye pressure or unreadable images were invited back for complete eye examination Visit 2 at primary care physician offices to confirm diagnosis. If final IOP > 30 mm Hg, participant Fast Tracked to Visit 2.Phase II Included confirmation dilated eye exam (Visit 2) for qualifying participants with ocular hypertension or glaucoma. Participants were randomized into an Enhanced Intervention Group then referred to a general ophthalmologist for follow-up eye care. The Enhanced Intervention Group was assigned a patient navigator and social worker and scheduled for an initial follow-up visit based on recommendations from study physicians at Visit 2. Prior to all follow-up visits, participants were given a scheduled appointment and received personal phone call reminders. Patients received necessary interpretation services and educational materials. Phase III consisted of tracking the Enhanced Intervention Group for compliance of attending recommended ophthalmic visits after Visit 2 during a 5 year period. Tracking was performed by the research team.Phase II Included confirmation dilated eye exam (Visit 2) for qualifying participants with ocular hypertension or glaucoma. Participants were randomized into a Usual Care Group then referred to a general ophthalmologist for follow-up eye care. The Usual Care Group was scheduled for an initial follow-up visit based on recommendations from study physicians at Visit 2. This option represents a realistic choice currently available to patients. Practice patterns vary depending on resources, staff time, and services available within each local ophthalmology practice. Phase III consisted of tracking the Usual Care Group for compliance of attending recommended ophthalmic visits after Visit 2 during a 5 year period. Tracking was performed by the research team.
Period Title: Phase I. Telemedicine Screening
STARTED90600
COMPLETED90600
NOT COMPLETED000
Period Title: Phase I. Telemedicine Screening
STARTED0275276
COMPLETED0171171
NOT COMPLETED0104105
Period Title: Phase I. Telemedicine Screening
STARTED0171171
COMPLETED07766
NOT COMPLETED094105

Baseline Characteristics

Arm/Group TitleTelemedicine Screening Participants - Phase 1
Arm/Group DescriptionPhase 1: Participants from geographically underserved locations across the Philadelphia, PA region were invited to participate in a free glaucoma eye screening at their primary care physician offices or health centers which included taking images of optic nerve and macula using a non-contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) and measuring Intraocular Pressure (IOP) in millimeters of mercury (mm Hg) with a non-contact rebound tonometer TA01I (ICare, Helsinki, Finland). Visual acuity was measured with correction, if patient had glasses or contact lenses, using the digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA) and medical, family and ocular history were recorded
Overall Participants906
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
635
70.1%
>=65 years
271
29.9%
Sex: Female, Male (Count of Participants)
Female
553
61%
Male
353
39%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
123
13.6%
Not Hispanic or Latino
770
85%
Unknown or Not Reported
13
1.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
49
5.4%
Native Hawaiian or Other Pacific Islander
1
0.1%
Black or African American
550
60.7%
White
154
17%
More than one race
15
1.7%
Unknown or Not Reported
137
15.1%
Region of Enrollment (participants) [Number]
United States
906
100%
Screening categories (Count of Participants)
Scheduled participants
541
59.7%
Walk-in participants
365
40.3%

Outcome Measures

1. Primary Outcome
TitleFundus Camera Images Via Telemedicine
DescriptionPhase 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 Frame1 hour eye exam

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTelemedicine Screening Participants
Arm/Group DescriptionPhase I. Participants recruited from diverse underserved locations across the Philadelphia region from community partners. Community partners included Public Health Management Corporation (4 centers), Philadelphia Department of Public Health (1 center), Health Federation of Philadelphia (2 centers), and Temple Physicians Inc (7 primary care offices). Offices and health centers selected based on zip code. Screenings consisted of a non contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) to center images on the optic nerve and macula. Trained ocular technicians captured 2 posterior and 1 anterior images per eye (6 total photographs). Intraocular pressure (IOP) in millimeters of mercury (mm Hg) was assessed 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. Visual acuity measured with correction, if patient had glasses or contact lenses, using the digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA). Medical, family and ocular history were recorded.
Measure Participants906
Normal fundus images
355
39.2%
Abnormal fundus images
384
42.4%
Unreadable images
167
18.4%
2. Primary Outcome
TitleIntraocular Pressure
DescriptionPhase 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 Frame1 hour eye exam

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTelemedicine Screening Participants
Arm/Group DescriptionPhase I. Participants recruited from diverse underserved locations across the Philadelphia region from community partners. Community partners included Public Health Management Corporation (4 centers), Philadelphia Department of Public Health (1 center), Health Federation of Philadelphia (2 centers), and Temple Physicians Inc (7 primary care offices). Offices and health centers selected based on zip code. Screenings consisted of a non contact, autofocus, hand-held fundus camera (Volk Optical, Mentor, Ohio, USA) to center images on the optic nerve and macula. Trained ocular technicians captured 2 posterior and 1 anterior images per eye (6 total photographs). Intraocular pressure (IOP) in millimeters of mercury (mm Hg) was assessed 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. Visual acuity measured with correction, if patient had glasses or contact lenses, using the digital acuity system ClearChart 2 (Reichert Technologies, Depew, New York, USA). Medical, family and ocular history were recorded.
Measure Participants906
IOP 30-34 mmHg
10
1.1%
IOP 35-39 mmHg
3
0.3%
IOP >39 mmHg
2
0.2%
IOP 22-29 mmHg
728
80.4%
IOP <21 mmHg
163
18%
3. Primary Outcome
TitleDiagnostic Image Confirmation by Ophthalmologist
DescriptionPhase 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 Frame1 hour eye examination

Outcome Measure Data

Analysis Population Description
355 of 906 participants of telemedicine screen Visit 1 did not require follow-up visits.
Arm/Group TitleTelemedicine Screening Participants
Arm/Group DescriptionPhase I. Participants with suspicious findings, high eye pressure or unreadable images from the telemedicine screening Visit 1 were referred for a complete dilated eye examination and visual field by study team and Ophthalmologist at Visit 2 within 6 months.
Measure Participants551
Glaucoma
38
4.2%
Glaucoma Suspects
159
17.5%
Ocular Hypertension
25
2.8%
Anatomically narrow angles
23
2.5%
IOP >30 mmHg
15
1.7%
Other retinal diseases
84
9.3%
Declined or Lost to Follow-up
207
22.8%
4. Secondary Outcome
TitleAdherence to Follow-up Ophthalmic Care.
DescriptionPhase 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.
Time Frame5 year follow-up period.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time FramePhases 1 and 2: 1 hour eye examinations. Phase 3: 5 year follow-up period.
Adverse Event Reporting Description Of the 551 Phase 1 participants qualifying for Phase 2 (Visit 2), 209 were Lost to Follow-up.
Arm/Group TitlePhase 1: Telemedicine Screening ParticipantsPhases 2/3: Enhanced Intervention GroupPhases 2/3: Usual Care Group
Arm/Group DescriptionPhase 1. 906 participants completed telemedicine screening with non contact fundus images, non contact intraocular pressure measurements, visual acuity and history recorded.Phase 2. 171 participants completing Visit 2 then randomized to the Enhanced Intervention Group for follow-up eye care. Phase 3. Includes following this group over a 5 year period for adherence to eye care.Phase 2. 171 participants completing Visit 2 then randomized to the Usual Care Group for follow-up eye care. Phase 3. Includes following this group over a 5 year period for adherence to eye care.
All Cause Mortality
Phase 1: Telemedicine Screening ParticipantsPhases 2/3: Enhanced Intervention GroupPhases 2/3: Usual Care Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/906 (0%) 0/171 (0%) 0/171 (0%)
Serious Adverse Events
Phase 1: Telemedicine Screening ParticipantsPhases 2/3: Enhanced Intervention GroupPhases 2/3: Usual Care Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/906 (0%) 0/171 (0%) 0/171 (0%)
Other (Not Including Serious) Adverse Events
Phase 1: Telemedicine Screening ParticipantsPhases 2/3: Enhanced Intervention GroupPhases 2/3: Usual Care Group
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/906 (0%) 0/171 (0%) 0/171 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. L. Jay Katz
OrganizationWills Eye Hospital
Phone215-825-4713
Emailjmolineaux@willseye.org
Responsible Party:
L. Jay Katz MD, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT02390245
Other Study ID Numbers:
  • 14-441
First Posted:
Mar 17, 2015
Last Update Posted:
Mar 11, 2022
Last Verified:
Dec 1, 2021