Evaluation of the Repeatability and Reproducibility of Co... | NCT02781948

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

NCT02781948

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 27, 2016Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Cornea

Interventions

Optical Coherence Tomography

Countries

Not provided

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

May 2016

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

May 2016

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

May 17, 2016

First Submission Date that Met QC Criteria

May 24, 2016

First Posted Date

May 25, 2016Estimated

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 23, 2016

Last Update Posted Date

Sep 27, 2016Estimated

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

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.

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

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography	Device		Corneal condition Normal

Measure	Description	Time Frame
Epithelial thickness		Day 1

Measure	Description	Time Frame
Corneal thickness		Day 1

Measure	Description	Time Frame
Stromal thickness		Day 1

Eligibility Module

Eligibility Criteria

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.

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

ID	Term
D003316	Corneal Diseases

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided