Cataract, Glaucoma, Macular Degeneration
Conditions
Keywords
screening, tele-ophthalmology
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.
Interventions
OTHERTechnology-based Eye Care Services (TECS) Protocol
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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients appropriately referred from the TECS protocol | Evaluation visit (Day 0) | Total number of participants with a referral for face to face eye care with and without OCT |
| Number of participants with an accurate diagnosis for anterior segment disease | Evaluation visit (Day 0) | 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. |
| Inter-reader variability of the TECS protocol | Evaluation visit (Day 0) | Kappa statistics reflecting the agreement between two readers on the same photo set of a single patient with and without OCT |
| Intra-reader variability of the TECS protocol | Evaluation visit (Day 0) | 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. |
Countries
United States
Outcome results
None listed