Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Technology-based Eye Care Services (TECS) Compare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02558712
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
April Maa, 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.

Condition or disease Intervention/treatment Phase
Cataract Macular Degeneration Glaucoma Other: Technology-based Eye Care Services (TECS) Protocol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known acute or chronic ocular issues

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: April Maa, MD Emory University

Layout table for additonal information
Responsible Party: April Maa, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02558712    
Other Study ID Numbers: IRB00080630
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Keywords provided by April Maa, Emory University:
screening
tele-ophthalmology
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Cataract
Eye Diseases
Retinal Degeneration
Retinal Diseases
Lens Diseases