Sponsor study identifier
Secondary identifiers
OTHER_GRANT · SNF
observational
480
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
April 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 27, 2007
Actual (reported)June 29, 2007
Actual (reported)December 2010
Actual (reported)April 30, 2018
Actual (reported)Incidence of development of late AMD
End of study
Patients with early ARM
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern, Switzerland
Wolf-Schnurrbusch UE, Wittwer VV, Ghanem R, Niederhaeuser M, Enzmann V, Framme C, Wolf S. Blue-light versus green-light autofluorescence: lesion size of areas of geographic atrophy. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9497-502. doi: 10.1167/iovs.11-8346.
Rothenbuehler SP, Wolf-Schnurrbusch UE, Wolf S. Macular pigment density at the site of altered fundus autofluorescence. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):499-504. doi: 10.1007/s00417-010-1528-1. Epub 2010 Sep 28.
Sebastian Wolf, MD
University of Bern
Sebastian Wolf, MD PhD
University of Bern
480 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2007
First Posted
June 29, 2007
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
April 30, 2018
Actual (reported)Last Updated
May 3, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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