Evaluation of RTVue in Corneal Measurement | NCT01220193

Studies
Evaluation of RTVue in Corneal Measurement

NCT01220193

Sponsor

Optovue

Status

Completed

Last Update Posted

Feb 18, 2011Estimated

Enrollment

196Estimated

Phase

Not provided

Conditions

Normal Cornea
Post Laser Refractive Surgery
Cornea Pathology
Cataract Surgery

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

Feb 2011

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

Apr 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 11, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

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

Feb 16, 2011

Last Update Posted Date

Feb 18, 2011Estimated

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

196Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal cornea:

18 years of age or older
No corneal pathology
No prior ocular surgery and no prior laser refractive surgery

Post laser refractive surgery:

18 years of age or older
No corneal pathology
No prior ocular surgery except laser refractive surgery
At least 1 week post laser refractive surgery without complication

Corneal pathology:

18 years of age or older
Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)
No prior laser refractive surgery

Cataract surgery:

18 years of age or older
No corneal pathology
No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery
Post surgery visit shall only include eyes without complication

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

Various ocular conditions to include normal, pathology, post refractive surgery and cataract.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gordon Binder & Weiss Vision Institute		San Diego	California	92122	United States
Brass Eye Center