Prevalence of Dyschromatopsia in Glaucoma Patients

November 19, 2013 updated by: Massachusetts Eye and Ear Infirmary

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Result from Ishihara Test
Time Frame: Visit 1
Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.
Visit 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glaucoma stage
Time Frame: Visit 1
Visual field will be tested with 30-2 Humphrey visual field full threshold test. Visual field defects will we graded following the Hodapp-Anderson-Parrish Scale (Hodapp E, Parrish RK, Anderson DR. Classification of Defects in Clinical Decisions in Glaucoma. St. Louis: Mosby, 1993:52-61).
Visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Douglas J. Rhee, M.D., Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 356715-1 Dyschromatopsia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma

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