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Trial record 77 of 81 for:    CRVO - Central Retinal Vein Occlusion

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

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ClinicalTrials.gov Identifier: NCT02390245
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : July 4, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Westat
Public Health Management Corporation
Philadelphia Department of Public Health
The Health Federation of Philadelphia
Temple Physicians, Inc.
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Glaucoma Suspect 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 Other: Use of patient navigation and social worker Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Enhanced Intervention Group
Use of patient navigation and social worker: Patients randomized to Group 1 will be referred to a general ophthalmologist close to the current health center or PCP office where they received the undilated eye exam. Prior to all follow-up visits, patients in the enhanced group who have scheduled an appointment will receive a personal phone call reminding them to attend. These patients will receive any necessary interpretation services and educational materials.
Other: Use of patient navigation and social worker
This arm will include phoning patients to schedule appointments; confirming appointments by mailings, emails and/or text messaging; arranging transportation through Customized Community Transportation (CCT) and Philadelphia Paratransit Service; and scheduling trained medical interpreters.

No Intervention: Usual care group
Patients randomized to Group 2 will be recommended to follow-up for eye care with a local ophthalmologist. These patients will be scheduled for their initial follow-up visit based on the recommendations of our study physicians so the research team is able to track outcomes. Group 2 represents a realistic choice currently available for patients. Practice patterns will vary depending on the resources, staff time, and services available within each local ophthalmology practice.



Primary Outcome Measures :
  1. To estimate the positive predictive value (PPV) of the teleophthalmology intervention for diagnosing of glaucoma [ Time Frame: 15 months ]
    We hypothesize that the diagnosis of glaucoma and glaucoma suspect using undilated optic disc images, tonometry pressure results, and medical history will predict the comprehensive eye exam diagnosis. That is, we will calculate the proportion of patients diagnosed with glaucoma or glaucoma suspect whose diagnosis was confirmed at Visit 2 with an exact two-sided binomial confidence interval. We will conclude that the telemedicine intervention has good performance if the lower bound of the confidence interval is above 80%


Secondary Outcome Measures :
  1. Attendance at recommended follow-up visits (Visit 4 and later) [ Time Frame: 5 years ]

    Since the expected number of appointments will differ based on diagnosis and disease severity, which may change over time, attendance will be summarized annually.

    For each year under observation, an expected number of visits will be determined based on the recommended follow-up at the first visit for that year. For purposes of this calculation, attendance at appointments within 13 months of the first visit will be assessed. We recognized that follow-up recommendations will vary for each patient depending on eye pressure control, medication adherence, disease severity, and surgery/laser appointments. Therefore, the research team, in conjunction with Dr. Blecher and the CDC, will plan and develop definitions of adherence for patients during Visits 3-8




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390245


Locations
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United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Centers for Disease Control and Prevention
Westat
Public Health Management Corporation
Philadelphia Department of Public Health
The Health Federation of Philadelphia
Temple Physicians, Inc.
Investigators
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Principal Investigator: 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: L. Jay Katz MD, MD, Wills Eye
ClinicalTrials.gov Identifier: NCT02390245     History of Changes
Other Study ID Numbers: 14-441
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A methods paper with year-1 baseline data and cost analysis has been published. Additional scientific manuscripts are under development.
Supporting Materials: Study Protocol
Time Frame: upon request
Access Criteria: upon request

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Artery Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Arterial Occlusive Diseases
Glaucoma
Macular Degeneration
Cataract
Ocular Hypertension
Diabetic Retinopathy
Vision, Low
Epiretinal Membrane
Eye Diseases
Lens Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Thrombosis
Embolism and Thrombosis
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms