Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Age Related Maculopathy Clinical Trial

— LUTEGA  

Official title:

Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763659
• Other study ID #: 2032-06/07
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: July 19, 2012
• Start date: May 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• All non- exudative forms of age related maculopathy

Exclusion Criteria:

• Exudative age related maculopathy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age Related Maculopathy

Intervention

Dietary Supplement:
• Lutein/ Zeaxanthin + Omega-3-FA
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
• Lutein/ Zeaxanthin + Omega-3-FA
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
• Placebo
0 mg Lutein, Zeaxanthin, Omega-3-FA

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University Hospital	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical density of macular pigment		12 months	No