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

Sponsor
Optovue (Industry)
Overall Status
Completed
CT.gov ID
NCT02781948
Collaborator
(none)
60
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical Coherence Tomography

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Normal

Not having any history of refractive surgery, contact lens, dry eye or pathology

Device: Optical Coherence Tomography

Corneal condition

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

Device: Optical Coherence Tomography

Outcome Measures

Primary Outcome Measures

  1. Epithelial thickness [Day 1]

Secondary Outcome Measures

  1. Corneal thickness [Day 1]

Other Outcome Measures

  1. Stromal thickness [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Optovue

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Optovue
ClinicalTrials.gov Identifier:
NCT02781948
Other Study ID Numbers:
  • 200-50997
First Posted:
May 25, 2016
Last Update Posted:
Sep 27, 2016
Last Verified:
May 1, 2016

Study Results

No Results Posted as of Sep 27, 2016