Overview

This trial is active, not recruiting.

Condition age related maculopathy
Sponsor University Hospital Inselspital, Berne
Start date October 2005
End date December 2010
Trial size 500 participants
Trial identifier NCT00494325, KEK 73/05, SNF 3200 Bo-109962/1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Incidence of development of late AMD
time frame: End of study

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - age related maculopathy Exclusion Criteria: - other macular diseases

Additional Information

Official title The Role of Macular Pigment in Patients With Age-related Macular Degeneration
Principal investigator Ute Wolf-Schnurrbusch, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Hospital Inselspital, Berne.