NCT01220193

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 18, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

October 11, 2010

Last Update Submit

February 16, 2011

Conditions

Normal CorneaPost Laser Refractive SurgeryCornea PathologyCataract Surgery

Study Arms (4)

Normal cornea

Post laser refractive surgery

Cornea pathology

Cataract surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Normal cornea:
  • years of age or older
  • No corneal pathology
  • No prior ocular surgery and no prior laser refractive surgery
  • Post laser refractive surgery:
  • 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:
  • 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:
  • years of age or older
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gordon Binder & Weiss Vision Institute

San Diego, California, 92122, United States

Location

Brass Eye Center

Latham, New York, 12110, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 18, 2011

Record last verified: 2011-02

Locations

US(2)