NCT02600546

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 5, 2015

Last Update Submit

March 28, 2016

Conditions

Repeatability & Reproducibility

Outcome Measures

Primary Outcomes (1)

  • epithelial thickness

    Day 1

Secondary Outcomes (1)

  • Stromal thickness

    Day 1

Eligibility Criteria

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

Seeing eye doctor for routine or follow-up care

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 30, 2016

Record last verified: 2015-11

Locations

US(1)