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OpenTrials
Completed

NCT Number: NCT00430287

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

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).

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Correlation of DDLS Grading to OCT, HRT, and HVF

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 1, 2007
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.