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

Completed

• Conditions: Cornea
• Interventions: Device: OCT

• Registration Number: NCT02775097
• Lead Sponsor: Optovue

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	OCT	Not having any history of refractive surgery, contact lens, dry eye or pathology
Corneal condition	OCT	History of refractive surgery, contact lens, dry eye or keratoconus.

Primary Outcome Measures

Name	Time	Method
Epithelial thickness	Day 1

Secondary Outcome Measures

Name	Time	Method
Corneal thickness	Day 1