Technology-based Eye Care Services (TECS) Compare
Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
1 other identifier
interventional
256
1 country
1
Brief Summary
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2017
CompletedApril 13, 2018
April 1, 2018
1.5 years
September 21, 2015
April 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Clinical diagnosis in dichotomous (yes/no) decision tree. The clinical diagnosis of the TECS protocol readers will be compared to the face to face physician, with the face to face serving as the standard of care. The results will be done with and without OCT. Sensitivity, specificity, positive and negative predictive value will be calculated before and after OCT.
Evaluation Visit (Day 0)
Secondary Outcomes (4)
Number of patients appropriately referred from the TECS protocol
Evaluation visit (Day 0)
Number of participants with an accurate diagnosis for anterior segment disease
Evaluation visit (Day 0)
Inter-reader variability of the TECS protocol
Evaluation visit (Day 0)
Intra-reader variability of the TECS protocol
Evaluation visit (Day 0)
Study Arms (1)
Face to face exam
OTHERStandard of clinical care, 8 point eye exam
Interventions
Extensive History will be taken. Distance auto-refraction measurements will be made on both eyes. Eye pressure using the iCare tonometer and central corneal thickness (CCT) using the corneal pachymeter will be taken for each eye. Participants will have fundus photos taken following the standard VA diabetic teleretinal protocol. Then participants will have OCT Macula and Nerve performed. After protocol complete, then patients will see an ophthalmologist for standard eye exam.
Eligibility Criteria
You may qualify if:
- Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
You may not qualify if:
- Known acute or chronic ocular issues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
April Maa, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 21, 2015
First Posted
September 24, 2015
Study Start
March 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 23, 2017
Last Updated
April 13, 2018
Record last verified: 2018-04