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

Open Angle Glaucoma Clinical Trial

Official title:

Correlation of DDLS Grading to OCT, HRT, and HVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430287
• Other study ID #: 06-775
• Status: Completed
• Phase: N/A
• First received: January 30, 2007
• Last updated: November 8, 2016
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Locations

Country	Name	City	State
United States	Wills Eye Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,