Technology-based Eye Care Services (TECS) Compare

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558712
• Other study ID #: IRB00080630
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: April 12, 2018
• Start date: March 2016
• Est. completion date: September 23, 2017

Study information

• Verified date: April 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: September 23, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Known acute or chronic ocular issues

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation Visit (Day 0)
Secondary	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	Evaluation visit (Day 0)
Secondary	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.	Evaluation visit (Day 0)
Secondary	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	Evaluation visit (Day 0)
Secondary	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.	Evaluation visit (Day 0)