Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 256
- Locations
- 2
- Primary Endpoint
- Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Study Overview
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.
Detailed Description
Patients will sign informed consent to enter the one visit study. They will undergo the study protocol and then see the face to face physician on the same day.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
Exclusion Criteria
- •Known acute or chronic ocular issues
Arms & Interventions
Face to face exam
Standard of clinical care, 8 point eye exam
Intervention: Technology-based Eye Care Services (TECS) Protocol (Other)
Outcomes
Primary Outcomes
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Time Frame: Evaluation Visit (Day 0)
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.
Secondary Outcomes
- 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))
Investigators
April Maa
Assistant Professor
Emory University