Technology-based Eye Care Services (TECS) Compare

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam

Conditions
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Cataract, Macular Degeneration, Glaucoma

Intervention / Treatment
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* Other: Technology-based Eye Care Services (TECS) Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic Exclusion Criteria: Known acute or chronic ocular issues

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Face to face exam<br>Standard of clinical care, 8 point eye exam | Other: Technology-based Eye Care Services (TECS) Protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients appropriately referred from the TECS protocol | Total number of participants with a referral for face to face eye care with and without OCT | Evaluation visit (Day 0) | 
| Number of participants with an accurate diagnosis for anterior segment disease | The responses from an anterior segment questionnaire will be compared to the findings of the face to face physician exam for accuracy, using a (yes/no) decision tree. Sensitivity, specificity will be calculated using the face to face exam as the standard of care. | Evaluation visit (Day 0) | 
| Inter-reader variability of the TECS protocol | Kappa statistics reflecting the agreement between two readers on the same photo set of a single patient with and without OCT | Evaluation visit (Day 0) | 
| Intra-reader variability of the TECS protocol | Kappa statistics measuring agreement of the same reader reading the photographs of the same patient twice (after a washout period between photo reading sets) with and without OCT. | Evaluation visit (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, tele-ophthalmology