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Completed

NCT Number: NCT02558712

Technology-based Eye Care Services (TECS) Compare

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

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Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Macular Degeneration Ocular Hypertension Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known acute or chronic ocular issues

Treatment and study plan

Technology-based Eye Care Services (TECS) Protocol

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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