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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430287
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : November 10, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jonathon Myers, Wills Eye

Brief Summary:
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).

Condition or disease
Open Angle Glaucoma

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of DDLS Grading to OCT, HRT, and HVF
Study Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

1: Primary open angle glaucoma
Patients with a form of primary open angle glaucoma
2: No known eye disease (controls)
Patients with no known eye disease (controls)

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
glaucoma service

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430287

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Merck Sharp & Dohme Corp.
Principal Investigator: Jonathan S Myers, MD Wills Eye Glaucoma Service

Responsible Party: Jonathon Myers, Attending Surgeon, Wills Eye Identifier: NCT00430287     History of Changes
Other Study ID Numbers: 06-775
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A manuscript has been published.

Keywords provided by Jonathon Myers, Wills Eye:
primary open angle glaucoma
low tension glaucoma
pigmentary glaucoma
exfoliative glaucoma

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases