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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sebastian Wolf, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00494325
First received: June 27, 2007
Last updated: December 13, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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
Study Population

Patients with early ARM

Criteria

Inclusion Criteria:

  • age related maculopathy

Exclusion Criteria:

  • other macular diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494325

Locations
Switzerland
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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 November 27, 2014