Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension), Ocular, Ocular, Ocular, Ocular, Ocular, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Ophthalmology
Healthy:No
Age Range:40 - Any
Updated:5/4/2017
Start Date:September 2014
End Date:December 2019

Use our guide to learn which trials are right for you!

Our 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 macular images 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:

- Phase 1 will consist of recruiting approximately 900 patients from primary care offices
and federally qualified health centers across Philadelphia and Chester counties. Using
telemedicine, we will detect eye disease at Visit 1, followed by a comprehensive eye
exam by a glaucoma specialist in the primary care setting to confirm the diagnosis
(Visit 2). Based on preliminary data, 50% of patients will have abnormal optic nerve
and/or macular images. The predictive accuracy of the 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 343 patients to either the
usual care group (n=171) or the enhanced intervention group (n=172) and scheduling
follow-up eye exams with a local, general ophthalmologist in an office-based setting
(Visit 3). The enhanced intervention will consist of using patient navigators and a
social worker to reduce barriers to follow-up eye care.

- Phase 3 will involve following patients for proximal (1-2 months) and distal (3 years)
follow-up care appointments (Visits 3-8) with a local ophthalmologist. Adherence to
follow-up recommendations for eye care will be the primary outcome measure. A
comprehensive cost study to estimate the 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.

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
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials