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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220193
Other study ID # RTVue 100 - 2009
Secondary ID
Status Completed
Phase N/A
First received October 11, 2010
Last updated February 16, 2011
Start date April 2009
Est. completion date December 2010

Study information

Verified date February 2011
Source Optovue
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Brass Eye Center Latham New York
United States Gordon Binder & Weiss Vision Institute San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Optovue

Country where clinical trial is conducted

United States, 

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