Clinical Validation Study of RTVue Features

NCT ID: NCT01370850

Last Updated: 2011-06-10

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

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-04-30

Brief Summary

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To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Detailed Description

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Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Conditions

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Healthy Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Normal results from the clinical exam and free of ocular pathology.

No interventions assigned to this group

Glaucoma

Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.

No interventions assigned to this group

Retina

Clinical exam results consistent with retina pathology.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
* Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
* Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria

* Normal subjects will be free of any ocular pathology.
* Glaucoma patients will be free of any ocular pathology except glaucoma.
* Retina patients will be free of any ocular pathology except any type of retina 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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Optovue

Principal Investigators

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Mike Sinai, PhD

Role: STUDY_DIRECTOR

Optovue

Locations

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Pacific Eye Specialists

Daly City, California, United States

Site Status

Countries

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United States

Other Identifiers

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RTVue Validation Study

Identifier Type: -

Identifier Source: org_study_id

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