NCT00430287

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

January 30, 2007

Last Update Submit

November 8, 2016

Conditions

Open Angle Glaucoma

Keywords

primary open angle glaucomalow tension glaucomapigmentary glaucomaexfoliative glaucoma

Study Arms (2)

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)

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

glaucoma service

You may qualify if:

  • Vision 20/50 or better
  • Less than 3 diopters of astigmatism
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleLow Tension Glaucoma

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Study Officials

  • Jonathan S Myers, MD

    Wills Eye Glaucoma Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

A manuscript has been published.

Locations

US(1)