An interventional study of Technology-based Eye Care Services (TECS) Protocol in Cataract, Macular Degeneration and Glaucoma, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by Emory University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 256 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of clinical care, 8 point eye exam
Other: Technology-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.
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.
Time frame: Evaluation Visit (Day 0)
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Evaluation visit (Day 0)
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Emory University