Technology-based Eye Care Services (TECS) Compare

April 12, 2018 updated by: April Maa, Emory University

Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam

The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Known acute or chronic ocular issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluation Visit (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Evaluation visit (Day 0)
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.
Evaluation visit (Day 0)
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
Evaluation visit (Day 0)
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.
Evaluation visit (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: April Maa, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 23, 2017

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00080630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on Technology-based Eye Care Services (TECS) Protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe