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NCT02781948 Clinical Trial

Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT

Cornea Clinical Trial

Official title:
Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02781948
Other study ID # 200-50997
Secondary ID
Status Completed
Phase N/A
First received May 17, 2016
Last updated September 23, 2016
Start date May 2016
Est. completion date August 2016

Study information
Verified date May 2016
Source Optovue
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Evaluate the repeatability and reproducibility of iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Normal

- Able and willing to provide consent.

- Able and willing to complete required exams. Corneal conditions

- Able and willing to provide consent.

- Able and willing to complete required exams.

- History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion Criteria:

Normal

- History of refractive surgery, contact lens, dry eye or pathology.

- Blepharitis or meibomitis

- Unable to complete required exams. Corneal conditions

- Unable to complete required exams.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Optical Coherence Tomography

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Optovue

Outcome
Type Measure Description Time frame Safety issue
Other Stromal thickness Day 1
Primary Epithelial thickness Day 1
Secondary Corneal thickness Day 1
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