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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Westat | OTHER |
| Public Health Management Corporation | OTHER |
| Philadelphia Department of Public Health |
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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.
The project will be divided into following parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free Eye Screenings | Other | This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Glaucoma Service | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28673747 | Result | 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. | |
| 34014814 |
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A methods paper with year-1 baseline data and cost analysis has been published. Additional scientific manuscripts are under development.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine Screening Participants - Phase 1 | Phase 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I. Telemedicine Screening |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2018 |
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| OTHER_GOV |
| Health Federation of Philadelphia | OTHER |
| Temple Physicians, Inc. | INDUSTRY |
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| 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. |
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| Usual Care | Other | This group will receive ophthalmic referral. |
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| 5 year follow-up period. |
| 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. |
| 30770354 | Derived | 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. |
| FG001 | Enhanced Intervention Group - Phases 2/3 | 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. |
| FG002 | Usual Care Group - Phases 2/3 | 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. |
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| NOT COMPLETED |
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| Phase 2. Randomization Into 2 Groups |
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| Phase 3. Ophthalmic Follow-up Adherence |
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Phase 1. Participants were recruited from diverse underserved locations across the Philadelphia region from community partners which 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 were selected based on zip code. Qualifying participants were offered the option of Phase 2 and 3 participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine Screening Participants - Phase 1 | Phase 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Screening categories | Participants were informed and invited ahead of scheduled screenings. During scheduled screenings, other individuals interested in participating were included as Walk-ins if inclusion/exclusion criteria was met. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 hour eye exam |
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| 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. | Posted | Count of Participants | Participants | 1 hour eye exam |
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| 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. | 355 of 906 participants of telemedicine screen Visit 1 did not require follow-up visits. | Posted | Count of Participants | Participants | 1 hour eye examination |
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| 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. | Posted | Count of Participants | Participants | 5 year follow-up period. |
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Phases 1 and 2: 1 hour eye examinations. Phase 3: 5 year follow-up period.
Of the 551 Phase 1 participants qualifying for Phase 2 (Visit 2), 209 were Lost to Follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Telemedicine Screening Participants | Phase 1. 906 participants completed telemedicine screening with non contact fundus images, non contact intraocular pressure measurements, visual acuity and history recorded. | 0 | 906 | 0 | 906 | 0 | 906 |
| EG001 | Phases 2/3: Enhanced Intervention Group | Phase 2. 172 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. | 0 | 172 | 0 | 172 | 0 | 172 |
| EG002 | Phases 2/3: Usual Care Group | Phase 2. 172 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. | 0 | 172 | 0 | 172 | 0 | 172 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L. Jay Katz | Wills Eye Hospital | 215-825-4713 | jmolineaux@willseye.org |
| Oct 29, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D003930 | Diabetic Retinopathy |
| D002386 | Cataract |
| D012170 | Retinal Vein Occlusion |
| D015356 | Retinal Artery Occlusion |
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D001157 | Arterial Occlusive Diseases |
| D012162 | Retinal Degeneration |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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