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

NCT ID: NCT00494325

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2018-04-30

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.

Conditions

Age Related Maculopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• age related maculopathy

Exclusion Criteria

• other macular diseases

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Wolf

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Sebastian Wolf, MD PhD

Role: STUDY_DIRECTOR

University of Bern

Locations

Klinik und Poliklinik für Augenheilkunde, University Bern

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 22110076 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20878175 (View on PubMed)

Other Identifiers

SNF 3200 Bo-109962/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KEK 73/05

Identifier Type: -

Identifier Source: org_study_id