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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date November 19, 2013
First Posted Date November 26, 2013
Last Update Posted Date November 26, 2013
Study Start Date November 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2013)		 Result from Ishihara Test [ Time Frame: Visit 1 ]
Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 19, 2013)		 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Dyschromatopsia in Glaucoma Patients
Official Title Prevalence of Dyschromatopsia in Glaucoma Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Open Angle Glaucoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 19, 2013)		 0
Original Actual Enrollment Same as current
Estimated Study Completion Date January 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01994564
Other Study ID Numbers 356715-1 Dyschromatopsia
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Massachusetts Eye and Ear Infirmary
Original Responsible Party Same as current
Current Study Sponsor Massachusetts Eye and Ear Infirmary
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Douglas J. Rhee, M.D. Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date July 2012