Back to resultsTechnology-based Eye Care Services (TECS) Compare
Primary Purpose
Cataract, Macular Degeneration, Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology-based Eye Care Services (TECS) Protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract focused on measuring screening, tele-ophthalmology
Eligibility Criteria
Inclusion Criteria:
- Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
Exclusion Criteria:
- Known acute or chronic ocular issues
Sites / Locations
- Atlanta VA Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Face to face exam
Arm Description
Standard of clinical care, 8 point eye exam
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02558712
Brief Title
Technology-based Eye Care Services (TECS) Compare
Official Title
Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Macular Degeneration, Glaucoma
Keywords
screening, tele-ophthalmology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face to face exam
Arm Type
Other
Arm Description
Standard of clinical care, 8 point eye exam
Intervention Type
Other
Intervention Name(s)
Technology-based Eye Care Services (TECS) Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
Description
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)
Secondary Outcome Measure Information:
Title
Number of patients appropriately referred from the TECS protocol
Description
Total number of participants with a referral for face to face eye care with and without OCT
Time Frame
Evaluation visit (Day 0)
Title
Number of participants with an accurate diagnosis for anterior segment disease
Description
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)
Title
Inter-reader variability of the TECS protocol
Description
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)
Title
Intra-reader variability of the TECS protocol
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
Exclusion Criteria:
Known acute or chronic ocular issues
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April Maa, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Technology-based Eye Care Services (TECS) Compare
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