NCT02781948

Brief Summary

Evaluate the repeatability and reproducibility of iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

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

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 17, 2016

Last Update Submit

September 23, 2016

Conditions

Cornea

Outcome Measures

Primary Outcomes (1)

  • Epithelial thickness

    Day 1

Secondary Outcomes (1)

  • Corneal thickness

    Day 1

Other Outcomes (1)

  • Stromal thickness

    Day 1

Study Arms (2)

Normal

Not having any history of refractive surgery, contact lens, dry eye or pathology

Device: Optical Coherence Tomography

Corneal condition

History of refractive surgery, contact lens, dry eye or keratoconus

Device: Optical Coherence Tomography

Interventions

Optical Coherence TomographyDEVICE
Corneal conditionNormal

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:

  • Normal
  • Able and willing to provide consent.
  • Able and willing to complete required exams. Corneal conditions
  • Able and willing to provide consent.
  • Able and willing to complete required exams.
  • History of refractive surgery, contact lens, dry eye or keratoconus.

You may not qualify if:

  • Normal
  • History of refractive surgery, contact lens, dry eye or pathology.
  • Blepharitis or meibomitis
  • Unable to complete required exams. Corneal conditions
  • Unable to complete required exams.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 25, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-05