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

Age Related Maculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494325
• Other study ID #: KEK 73/05
• Secondary ID: SNF 3200 Bo-1099
• Status: Completed
• Start date: October 2005
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 30, 2018
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age related maculopathy

Exclusion Criteria:

• other macular diseases

Related Conditions & MeSH terms

• Age Related Maculopathy
• Macular Degeneration

Locations

Country	Name	City	State
Switzerland	Klinik und Poliklinik für Augenheilkunde, University Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of development of late AMD		End of study