Evaluation of RTVue in Corneal Measurement

Cataract Surgery Clinical Trial

Official title:

Evaluation of RTVue in Corneal Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220193
• Other study ID #: RTVue 100 - 2009
• 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

Related Conditions & MeSH terms

• Cataract Surgery
• Cornea Pathology
• Normal Cornea
• Post Laser Refractive Surgery

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,