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Does the Optic Disc Grading Done Visually by Your Doctor Agree With Optic Nerve Testing Which is Done by Machines?

NCT ID: NCT00430287

Last Updated: 2016-11-10

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

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).

Detailed Description

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The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.

Conditions

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Open Angle Glaucoma

Keywords

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primary open angle glaucoma low tension glaucoma pigmentary glaucoma exfoliative glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: Primary open angle glaucoma

Patients with a form of primary open angle glaucoma

No interventions assigned to this group

2: No known eye disease (controls)

Patients with no known eye disease (controls)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Vision 20/50 or better
* Less than 3 diopters of astigmatism
* 3 diopters or less of myopia or hyperopia
* Pattern Standard Deviation on HVF less than 2.5dB in normals
* Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients

Exclusion Criteria

* Abnormalities of cornea or ocular media
* Significant ocular pathologies affecting visual field
* History of hypotony
* Ocular surgery within 6 months
* Nystagmus
* Unreliable visual fields
* OCT signal strength scan less than 6
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Jonathon Myers

Attending Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan S Myers, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Glaucoma Service

Locations

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Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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06-775

Identifier Type: -

Identifier Source: org_study_id