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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00430287
First received: January 30, 2007
Last updated: January 25, 2010
Last verified: November 2008
  Purpose

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
Open Angle Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of DDLS Grading to OCT, HRT, and HVF

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Enrollment: 101
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with a form of primary open angle glaucoma
2
Patients with no known eye disease (controls)

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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

glaucoma service

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430287

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

No publications provided

Responsible Party: Jonathan S. Myers, MD, Wills Eye Glaucoma Service
ClinicalTrials.gov Identifier: NCT00430287     History of Changes
Other Study ID Numbers: 06-775
Study First Received: January 30, 2007
Last Updated: January 25, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014