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Prevalence of Dyschromatopsia in Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994564
Recruitment Status : Withdrawn
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

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.


Condition or disease
Open Angle Glaucoma

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Dyschromatopsia in Glaucoma Patients
Study Start Date : November 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014





Primary Outcome Measures :
  1. Result from Ishihara Test [ Time Frame: Visit 1 ]
    Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994564


Locations
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United States, Massachusetts
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Douglas J. Rhee, M.D. Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
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Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01994564    
Other Study ID Numbers: 356715-1 Dyschromatopsia
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: July 2012
Keywords provided by Massachusetts Eye and Ear Infirmary:
OAG
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases