Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

September 23, 2016 updated by: Optovue
Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

89

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seeing eye doctor for routine or follow-up care

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
Not having any history of refractive surgery, contact lens, dry eye or pathology
Device: OCT
OCT for all Arms
Corneal condition
History of refractive surgery, contact lens, dry eye or keratoconus.
Device: OCT
OCT for all Arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epithelial thickness
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal thickness
Time Frame: Day 1
Day 1

Other Outcome Measures

Outcome Measure
Time Frame
Stromal thickness
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optovue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 200-50996

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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Conditions

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Drug Interventions

Dietary Supplements

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Locations

3
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