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

• Sponsor: Optovue (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02775097
• Collaborator: (none)
• Enrollment: 89
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea	Device: OCT

Study Design

• Study Type: Observational
• Actual Enrollment: 89 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Normal Not having any history of refractive surgery, contact lens, dry eye or pathology	Device: OCT; OCT for all Arms
Corneal condition History of refractive surgery, contact lens, dry eye or keratoconus.	Device: OCT; OCT for all Arms

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: NCT02775097
• Other Study ID Numbers: 200-50996
• First Posted: May 17, 2016
• Last Update Posted: Sep 27, 2016
• Last Verified: May 1, 2016

Study Results

No Results Posted as of Sep 27, 2016