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

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ClinicalTrials.gov Identifier: NCT00494325
Recruitment Status : Active, not recruiting
First Posted : June 29, 2007
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sebastian Wolf, University Hospital Inselspital, Berne

Study Description
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Brief Summary:
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 or disease
Age Related Maculopathy

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Macular Pigment in Patients With Age-related Macular Degeneration
Study Start Date : October 2005
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : December 2017

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Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of development of late AMD [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494325


Locations
Switzerland
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Sebastian Wolf, MD University of Bern
Study Director: Sebastian Wolf, MD PhD University of Bern
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sebastian Wolf, Director, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00494325     History of Changes
Other Study ID Numbers: KEK 73/05
SNF 3200 Bo-109962/1 ( Other Grant/Funding Number: SNF )
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases