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The Role of Macular Pigment in Patients With Age-Related Macular Degeneration

This study is currently recruiting participants.
Verified by University Hospital Inselspital, Berne, June 2008

Sponsored by: University Hospital Inselspital, Berne
Information provided by: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00494325
  Purpose

In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.


Condition
Age Related Maculopathy

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Macular Degeneration   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   The Role of Macular Pigment in Patients With Age-Related Macular Degeneration

Further study details as provided by University Hospital Inselspital, Berne:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   500
Study Start Date:   October 2005
Estimated Study Completion Date:   December 2009

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample

Study Population

Patients with early ARM


Criteria

Inclusion Criteria:

  • age related maculopathy

Exclusion Criteria:

  • other macular diseases
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494325

Contacts
Contact: Ute Wolf-Schnurrbusch, MD     ute.wolf@insel.ch    

Locations
Switzerland
Klinik und Poliklinik für Augenheilkunde, University Bern     Recruiting
      Bern, Switzerland

Sponsors and Collaborators
University Hospital Inselspital, Berne

Investigators
Principal Investigator:     Ute Wolf-Schnurrbusch, MD     University of Bern    
Study Director:     Sebastian Wolf, MD PhD     University of Bern    
  More Information


Responsible Party:   University Bern ( Sebastian Wolf )
Study ID Numbers:   KEK 73/05, SNF 3200 Bo-109962/1
First Received:   June 27, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00494325
Health Authority:   Switzerland: Ethikkommision

Keywords provided by University Hospital Inselspital, Berne:
age related maculopathy, macular pigment  

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on November 06, 2008




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