Technology-based Eye Care Services (TECS) Compare
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|ClinicalTrials.gov Identifier: NCT02558712|
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract Macular Degeneration Glaucoma||Other: Technology-based Eye Care Services (TECS) Protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 23, 2017|
Face to face exam
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 [ 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.
- Number of patients appropriately referred from the TECS protocol [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558712
|United States, Georgia|
|Atlanta VA Medical Center|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||April Maa, MD||Emory University|