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NCT02775097 Clinical Trial

Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

Cornea Clinical Trial

Official title:
Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02775097
Other study ID # 200-50996
Secondary ID
Status Completed
Phase N/A
First received May 10, 2016
Last updated September 23, 2016
Start date April 2016
Est. completion date July 2016

Study information
Verified date May 2016
Source Optovue
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: WIRB
Study type Observational

Clinical Trial Summary

Evaluate the accuracy of the RTVue-XR and 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 89
Est. completion date July 2016
Est. primary completion date June 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:
• OCT
OCT for all Arms

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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