Evaluation of Corneal Epithelial Thickness Mapping

NCT ID: NCT01712022

Last Updated: 2014-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.

Detailed Description

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Conditions

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Dry Eye and Contact Lens Wear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dry Eye

clinical diagnosis of dry eye

No interventions assigned to this group

Contact Lens

routine wear of contact lens

No interventions assigned to this group

Normal

Not having history of dry eye or contact lens wear or corneal pathology or surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Able and willing to provide consent
* Able and willing to complete the required examinations
* DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
* CONTACT LENS GROUP ONLY: Regular contact lens wear

Exclusion Criteria

* History of ocular surgery
* History of laser refractive surgery
* History of cataract surgery
* DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
* CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
* NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optovue

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fishman Vision

Palo Alto, California, United States

Site Status

Gordon-Weiss-Schanzlin Vision Institute

San Diego, California, United States

Site Status

Brass Eye Center

Latham, New York, United States

Site Status

Countries

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United States

Other Identifiers

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200-48071

Identifier Type: -

Identifier Source: org_study_id

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