Prevalence of Dyschromatopsia in Glaucoma Patients

Open Angle Glaucoma Clinical Trial

Official title:

Prevalence of Dyschromatopsia in Glaucoma Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01994564
• Other study ID #: 356715-1 Dyschromatopsia
• Status: Withdrawn
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 19, 2013
• Start date: November 2012
• Est. completion date: January 2014

Study information

• Verified date: July 2012
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Locations

Country	Name	City	State
United States	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result from Ishihara Test	Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.	Visit 1	No
Secondary	Glaucoma stage	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	No