NCT01994564

Brief Summary

Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. Furthermore, the retinal nerve fiber layers from different receptors for different colors are ordered in a special manner as well. Thus, it is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia). At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or only in end-stage glaucoma. By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma and in different stages of the disease will be investigated.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 26, 2013

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

November 19, 2013

Last Update Submit

November 19, 2013

Conditions

Keywords

OAG

Outcome Measures

Primary Outcomes (1)

  • Result from Ishihara Test

    Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.

    Visit 1

Secondary Outcomes (1)

  • Glaucoma stage

    Visit 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of open-angle glaucoma of the Glaucoma Department at Massachusetts Eye \& Ear Infirmary, Boston, MA 02114, US

You may qualify if:

  • diagnosis of open angle glaucoma
  • visual acuity \>/= 20/50
  • age \>/= 18 (no upper limit)
  • male or female gender

You may not qualify if:

  • other type of glaucoma
  • age \<18
  • other retinal disease (e.g. age related macular degeneration)
  • other disease affecting the optic nerve or the retinal nerve fibers
  • known color blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Douglas J. Rhee, M.D.

    Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 26, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

November 26, 2013

Record last verified: 2012-07

Locations