- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994564
Prevalence of Dyschromatopsia in Glaucoma Patients
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
Conditions
Study Type
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye & Ear Infirmary
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Douglas J. Rhee, M.D., Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
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