- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781948
Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT
September 23, 2016 updated by: Optovue
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
60
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
|
|
Corneal condition
History of refractive surgery, contact lens, dry eye or keratoconus
|
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
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
May 1, 2016
Primary Completion (ACTUAL)
July 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (ESTIMATE)
May 25, 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
- 200-50997
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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