Glaucoma Suspect, Glaucoma, 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
Conditions
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.
Interventions
OTHERFree Eye Screenings
This group will receive free eye screening and follow-up comprehensive ophthalmic exam if recommended.
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.
OTHERUsual Care
This group will receive ophthalmic referral.
Sponsors
Centers for Disease Control and Prevention
Westat
Public Health Management Corporation
Philadelphia Department of Public Health
Health Federation of Philadelphia
Temple Physicians, Inc.
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 906 |
| Total | 906 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Telemedicine Screening Participants - Phase 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 271 Participants |
| Age, Categorical Between 18 and 65 years | 635 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 123 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 770 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 49 Participants |
| Race (NIH/OMB) Black or African American | 550 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 137 Participants |
| Race (NIH/OMB) White | 154 Participants |
| Region of Enrollment United States | 906 participants |
| Screening categories Scheduled participants | 541 Participants |
| Screening categories Walk-in participants | 365 Participants |
| Sex: Female, Male Female | 553 Participants |
| Sex: Female, Male Male | 353 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 906 | 0 / 172 | 0 / 172 |
| other Total, other adverse events | 0 / 906 | 0 / 172 | 0 / 172 |
| serious Total, serious adverse events | 0 / 906 | 0 / 172 | 0 / 172 |
Outcome results
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.
Time frame: 1 hour eye examination
Population: 355 of 906 participants of telemedicine screen Visit 1 did not require follow-up visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Glaucoma | 38 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Glaucoma Suspects | 159 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Ocular Hypertension | 25 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Anatomically narrow angles | 23 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | IOP >30 mmHg | 15 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Other retinal diseases | 84 Participants |
| Telemedicine Screening Participants | Diagnostic Image Confirmation by Ophthalmologist | Declined or Lost to Follow-up | 207 Participants |
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.
Time frame: 1 hour eye exam
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Screening Participants | Fundus Camera Images Via Telemedicine | Normal fundus images | 355 Participants |
| Telemedicine Screening Participants | Fundus Camera Images Via Telemedicine | Abnormal fundus images | 384 Participants |
| Telemedicine Screening Participants | Fundus Camera Images Via Telemedicine | Unreadable images | 167 Participants |
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.
Time frame: 1 hour eye exam
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Screening Participants | Intraocular Pressure | IOP 30-34 mmHg | 10 Participants |
| Telemedicine Screening Participants | Intraocular Pressure | IOP 35-39 mmHg | 3 Participants |
| Telemedicine Screening Participants | Intraocular Pressure | IOP >39 mmHg | 2 Participants |
| Telemedicine Screening Participants | Intraocular Pressure | IOP 22-29 mmHg | 728 Participants |
| Telemedicine Screening Participants | Intraocular Pressure | IOP <21 mmHg | 163 Participants |
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.
Time frame: 5 year follow-up period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Screening Participants | Adherence to Follow-up Ophthalmic Care. | Attended visits in Year 1 according to ophthalmologist/optometrist recommendation | 32 Participants |
| Telemedicine Screening Participants | Adherence to Follow-up Ophthalmic Care. | Adherence to follow-up visits in Year 2 according to ophthalmologist/optometrist recommendation | 27 Participants |
| Telemedicine Screening Participants | Adherence to Follow-up Ophthalmic Care. | Attended Visit 4 according to ophthalmologist/optometrist recommendation | 97 Participants |
| Telemedicine Screening Participants | Adherence to Follow-up Ophthalmic Care. | Adherence to follow-up visits in Year 3 according to ophthalmologist/optometrist recommendation | 5 Participants |
| Telemedicine Screening Participants | Adherence to Follow-up Ophthalmic Care. | Attended Visit 3 within 12 months of randomization | 128 Participants |
| Usual Care Group - Phase III | Adherence to Follow-up Ophthalmic Care. | Adherence to follow-up visits in Year 3 according to ophthalmologist/optometrist recommendation | 1 Participants |
| Usual Care Group - Phase III | Adherence to Follow-up Ophthalmic Care. | Attended Visit 3 within 12 months of randomization | 67 Participants |
| Usual Care Group - Phase III | Adherence to Follow-up Ophthalmic Care. | Attended visits in Year 1 according to ophthalmologist/optometrist recommendation | 14 Participants |
| Usual Care Group - Phase III | Adherence to Follow-up Ophthalmic Care. | Attended Visit 4 according to ophthalmologist/optometrist recommendation | 39 Participants |
| Usual Care Group - Phase III | Adherence to Follow-up Ophthalmic Care. | Adherence to follow-up visits in Year 2 according to ophthalmologist/optometrist recommendation | 9 Participants |