Evaluation of Corneal Epithelial Thickness Mapping | NCT01712022

Studies
Evaluation of Corneal Epithelial Thickness Mapping

NCT01712022

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 11, 2014Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Dry Eye and Contact Lens Wear

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 19, 2012

First Submission Date that Met QC Criteria

Oct 19, 2012

First Posted Date

Oct 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry Eye		clinical diagnosis of dry eye
Contact Lens		routine wear of contact lens
Normal		Not having history of dry eye or contact lens wear or corneal pathology or surgery

Interventions

Not provided

Measure	Description	Time Frame
corneal epithelial thickness		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Able and willing to provide consent
Able and willing to complete the required examinations
DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
CONTACT LENS GROUP ONLY: Regular contact lens wear

Exclusion Criteria:

History of ocular surgery
History of laser refractive surgery
History of cataract surgery
DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

seeing eye doctor for routine or follow-up care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fishman Vision		Palo Alto	California	94301	United States
Gordon-Weiss-Schanzlin Vision Institute

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided