Trial Outcomes & Findings for Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study (NCT NCT02390245)
NCT ID: NCT02390245
Last Updated: 2022-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
906 participants
Primary outcome timeframe
1 hour eye exam
Results posted on
2022-08-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Phase I. Telemedicine Screening
STARTED
|
906
|
0
|
0
|
|
Phase I. Telemedicine Screening
COMPLETED
|
906
|
0
|
0
|
|
Phase I. Telemedicine Screening
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2. Randomization Into 2 Groups
STARTED
|
0
|
275
|
276
|
|
Phase 2. Randomization Into 2 Groups
COMPLETED
|
0
|
172
|
172
|
|
Phase 2. Randomization Into 2 Groups
NOT COMPLETED
|
0
|
103
|
104
|
|
Phase 3. Ophthalmic Follow-up Adherence
STARTED
|
0
|
172
|
172
|
|
Phase 3. Ophthalmic Follow-up Adherence
COMPLETED
|
0
|
77
|
66
|
|
Phase 3. Ophthalmic Follow-up Adherence
NOT COMPLETED
|
0
|
95
|
106
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Phase 2. Randomization Into 2 Groups
Lost to Follow-up
|
0
|
103
|
104
|
|
Phase 3. Ophthalmic Follow-up Adherence
Lost to Follow-up
|
0
|
95
|
106
|
Baseline Characteristics
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Baseline characteristics by cohort
| Measure |
Telemedicine Screening Participants - Phase 1
n=906 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
635 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
271 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
553 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
353 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
123 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
770 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
550 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
137 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
906 participants
n=93 Participants
|
|
Screening categories
Scheduled participants
|
541 Participants
n=93 Participants
|
|
Screening categories
Walk-in participants
|
365 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 hour eye examPhase 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.
Outcome measures
| Measure |
Telemedicine Screening Participants
n=906 Participants
Phase 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.
|
Usual Care Group - Phase III
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.
|
|---|---|---|
|
Fundus Camera Images Via Telemedicine
Normal fundus images
|
355 Participants
|
—
|
|
Fundus Camera Images Via Telemedicine
Abnormal fundus images
|
384 Participants
|
—
|
|
Fundus Camera Images Via Telemedicine
Unreadable images
|
167 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 hour eye examPhase 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.
Outcome measures
| Measure |
Telemedicine Screening Participants
n=906 Participants
Phase 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.
|
Usual Care Group - Phase III
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.
|
|---|---|---|
|
Intraocular Pressure
IOP >39 mmHg
|
2 Participants
|
—
|
|
Intraocular Pressure
IOP 30-34 mmHg
|
10 Participants
|
—
|
|
Intraocular Pressure
IOP 35-39 mmHg
|
3 Participants
|
—
|
|
Intraocular Pressure
IOP 22-29 mmHg
|
728 Participants
|
—
|
|
Intraocular Pressure
IOP <21 mmHg
|
163 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 hour eye examinationPopulation: 355 of 906 participants of telemedicine screen Visit 1 did not require follow-up visits.
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.
Outcome measures
| Measure |
Telemedicine Screening Participants
n=551 Participants
Phase 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.
|
Usual Care Group - Phase III
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.
|
|---|---|---|
|
Diagnostic Image Confirmation by Ophthalmologist
Glaucoma
|
38 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
Glaucoma Suspects
|
159 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
Anatomically narrow angles
|
23 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
IOP >30 mmHg
|
15 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
Other retinal diseases
|
84 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
Ocular Hypertension
|
25 Participants
|
—
|
|
Diagnostic Image Confirmation by Ophthalmologist
Declined or Lost to Follow-up
|
207 Participants
|
—
|
SECONDARY outcome
Timeframe: 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. 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.
Outcome measures
| Measure |
Telemedicine Screening Participants
n=172 Participants
Phase 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.
|
Usual Care Group - Phase III
n=172 Participants
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.
|
|---|---|---|
|
Adherence to Follow-up Ophthalmic Care.
Attended Visit 3 within 12 months of randomization
|
128 Participants
|
67 Participants
|
|
Adherence to Follow-up Ophthalmic Care.
Attended visits in Year 1 according to ophthalmologist/optometrist recommendation
|
32 Participants
|
14 Participants
|
|
Adherence to Follow-up Ophthalmic Care.
Attended Visit 4 according to ophthalmologist/optometrist recommendation
|
97 Participants
|
39 Participants
|
|
Adherence to Follow-up Ophthalmic Care.
Adherence to follow-up visits in Year 2 according to ophthalmologist/optometrist recommendation
|
27 Participants
|
9 Participants
|
|
Adherence to Follow-up Ophthalmic Care.
Adherence to follow-up visits in Year 3 according to ophthalmologist/optometrist recommendation
|
5 Participants
|
1 Participants
|
Adverse Events
Phase 1: Telemedicine Screening Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phases 2/3: Enhanced Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phases 2/3: Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place