GlaucomaNCT02390245
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
A study testing Free Eye Screenings and Enhanced Intervention in people with Glaucoma and Glaucoma Suspect, run by Wills Eye at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Glaucoma Suspect, Diabetic Retinopathy
- What is being tested?
- Free Eye Screenings and Enhanced Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any patient with previously diagnosed glaucoma, glaucoma suspect, or eye diseases who is currently being followed by an ophthalmologist
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Glaucoma, Glaucoma Suspect, Diabetic Retinopathy, Ocular Hypertension, Cataract, Branch Retinal Vein Occlusion
- Being tested
- Free Eye Screenings, Enhanced Intervention, Usual Care
- Medical subject headings
- Glaucoma, Ocular Hypertension, Diabetic Retinopathy, Cataract, Retinal Vein Occlusion, Retinal Artery Occlusion, Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Eye ScreeningsOther
This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.
Enhanced InterventionOther
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 CareOther
This group will receive ophthalmic referral.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 hour eye examination
Secondary outcomes (1)
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.
Measured: 5 year follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2019
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Westat, Public Health Management Corporation, Philadelphia Department of Public Health, Health Federation of Philadelphia, Temple Physicians, Inc.
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
- Investigators
- L. J Katz, MD, Principal investigator, Wills Eye HospitalLisa A Hark, PhD, Principal investigator, Wills Eye HospitalJulia A Haller, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390245
- Sponsor's protocol ID
- 14-441
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2015
- Last updated
- 22 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: A methods paper with year-1 baseline data and cost analysis has been published. Additional scientific manuscripts are under development.
Publications
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.
PubMed 28673747Leiby 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.
PubMed 34014814Hark 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.
PubMed 30770354
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
- ClinicalTrials.gov ID
- NCT02390245
- Acronym / sponsor ID
- 14-441
- Conditions
- Glaucoma, Glaucoma Suspect, Diabetic Retinopathy, Ocular Hypertension, Cataract, Branch Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Westat, Public Health Management Corporation, Philadelphia Department of Public Health, Health Federation of Philadelphia, Temple Physicians, Inc.
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Telemedicine Screening Participants | Experimental | Other: Free Eye ScreeningsParticipants 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). |
| Phases 2 and 3: Enhanced Intervention Group | Experimental | Other: Enhanced InterventionFrom 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. |
| Phases 2 and 3: Usual Care Group | Experimental | Other: Usual CareFrom 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Any patient with previously diagnosed glaucoma, glaucoma suspect, or eye diseases who is currently being followed by an ophthalmologist
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Eye ScreeningsThis group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended. | Other | Phase 1: Telemedicine Screening Participants |
| Enhanced InterventionThis 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. | Other | Phases 2 and 3: Enhanced Intervention Group |
| Usual CareThis group will receive ophthalmic referral. | Other | Phases 2 and 3: Usual Care Group |
Primary outcome
Fundus Camera Images Via Telemedicine
Time frame: 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.
Intraocular Pressure
Time frame: 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.
Diagnostic Image Confirmation by Ophthalmologist
Time frame: 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.
1 secondary outcome
Adherence to Follow-up Ophthalmic Care.
Time frame: 5 year follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28673747Hark 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 publication: PubMed 34014814Leiby 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.
- Derived from this study: PubMed 30770354Hark 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.
- Individual participant dataSharing planned: No. A methods paper with year-1 baseline data and cost analysis has been published. Additional scientific manuscripts are under development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. J Katz, MD principal investigator
Wills Eye Hospital
Lisa A Hark, PhD principal investigator
Wills Eye Hospital
Julia A Haller, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Eye Screenings and Enhanced Intervention in people with Glaucoma and Glaucoma Suspect, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundus Camera Images Via Telemedicine (time frame: 1 hour eye exam). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.