Evaluation of the Repeatability and Reproducibility of Co... | NCT02600546

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

NCT02600546

Sponsor

Optovue

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Repeatability & Reproducibility

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

Nov 2015

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 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Nov 5, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 2015Estimated

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

Mar 28, 2016

Last Update Posted Date

Mar 30, 2016Estimated

Description Module

Brief Summary

Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping in normal subjects and corneal patients.

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

62Actual

Measure	Description	Time Frame
epithelial thickness		Day 1

Measure	Description	Time Frame
Stromal thickness		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to provide consent.
Able and willing to complete required exams
History of refractive surgery, contact lens, dry eye or keratoconus for corneal patients

Exclusion Criteria:

Unable to complete required exams
History of refractive surgery, contact lens, dry eye or keratoconus for normal patients

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
Baylor College of Medicine		Houston	Texas	77030	United States