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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00563979
Other study ID # KEK 152/07
Secondary ID
Status Completed
Phase N/A
First received November 26, 2007
Last updated June 10, 2015
Start date July 2007
Est. completion date December 2009

Study information

Verified date June 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®.


Description:

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®. Primary variable for a significant change will be 10% increase compared to baseline MPD.

The measurement will be carried out by means of a modified confocal scanning laser ophthalmoscope (HRA) recording autofluorescence images at 488 nm and 514 nm 6. MPD is determined on MPD maps within 0.5 degrees around the center of the fovea. All MPD measurements and photographs will by performed by the Bern Photographic Reading Center (BPRC). Complete examination of study patients comprises testing of standardized visual acuity (ETDRS-VA), visual contrast sensitivity (CS), biomicroscopy, fundus photography, and a blood sample. Participating patients also have to fill out a food frequency questionnaire (FFQ-Bern) allowing for correction of additional lutein intake by regular diet. Moreover possible confounding factors e.g. as sunlight exposure or smoking habits will be assessed. Secondary objective of EMPOLS is the effect of oral non-compound ester lutein supplementation on CS and ETDRS-VA during one year. The variable for a significant change in ETDRS-VA is loss or gain of 7 letters on the ETDRS chart, for a change in CS: loss or gain of at least four letters on the Pelli-Robson CS Chart. Additionally, serum carotenoid levels of lutein will be determined by high performance liquid chromatography (HPLC) for each visit 1.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- age related maculopathy

Exclusion Criteria:

- exudative age related degeneration

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
VitaluxPlus®
1 tablet daily
Omega 3
1 tablet daily

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 Macular pigment density 6 months No
Secondary contrast sensitivity 6 months No
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