Technology-based Eye Care Services (TECS) Compare

Not Applicable

Completed

• Conditions: Cataract; Glaucoma; Macular Degeneration
• Interventions: Other: Technology-based Eye Care Services (TECS) Protocol

• Registration Number: NCT02558712
• Lead Sponsor: Emory University

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 Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-24
• Study Start: 2016-03
• Primary Completion: 2017-09
• Study Completion: 2017-09-23
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic

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Exclusion Criteria

• Known acute or chronic ocular issues

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Face to face exam	Technology-based Eye Care Services (TECS) Protocol	Standard of clinical care, 8 point eye exam

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States