The Role of Macular Pigment in Patients With Age-related Macular Degeneration
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Macular Pigment in Patients With Age-related Macular Degeneration |
- Incidence of development of late AMD [ Time Frame: End of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Patients with early ARM
Inclusion Criteria:
- age related maculopathy
Exclusion Criteria:
- other macular diseases
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00494325
| Switzerland | |
| Klinik und Poliklinik für Augenheilkunde, University Bern | |
| Bern, Switzerland | |
| Principal Investigator: | Ute Wolf-Schnurrbusch, MD | University of Bern | |
| Study Director: | Sebastian Wolf, MD PhD | University of Bern |
More Information
No publications provided by University Hospital Inselspital, Berne
Additional 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 |
| Study First Received: | June 27, 2007 |
| Last Updated: | December 13, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital Inselspital, Berne:
|
age related maculopathy, macular pigment |
Additional relevant MeSH terms:
|
Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases |
ClinicalTrials.gov processed this record on February 25, 2015