Clinical Validation Study for iVue

NCT ID: NCT01242553

Last Updated: 2017-09-28

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

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Detailed Description

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Conditions

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Normal and Ocular Pathology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Normal results from clinical exam and free of ocular pathology.

No interventions assigned to this group

Retina

Clinical exam results consistent with retina pathology

No interventions assigned to this group

Glaucoma

Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

No interventions assigned to this group

Cornea

Clinical exam results consistent with cornea pathology.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Normal: Normal results from clinical exam and free of ocular pathology.
* Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
* Cornea: Clinical exam results consistent with cornea pathology.
* Retina: Clinical exam results consistent with retina pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optovue

INDUSTRY

Sponsor Role lead

Responsible Party

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Optovue

Principal Investigators

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Michael Hee, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Eye Specialists

Nalin Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Retina Center

Michael Sinai, PhD

Role: STUDY_DIRECTOR

Optovue

Locations

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Pacific Eye Specialists

Daly City, California, United States

Site Status

Colorado Retina Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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iVue 100-2009

Identifier Type: -

Identifier Source: org_study_id