## Protocol Section
### Identification Module
**NCT ID:** NCT00563979

**Acronym:** EMPOLS

**Brief Title:** Enhancement of Macular Pigment Density by Oral Lutein Supplementation

**Official Title:** Enhancement of Macular Pigment Density by Oral Lutein Supplementation

#### Organization Study ID Info
**ID:** KEK 152/07
#### Organization
**Class:** OTHER
**Full Name:** Insel Gruppe AG, University Hospital Bern
### Status Module
#### Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Start Date
**Date:** 2007-07

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2007-11-27
**Type:** ESTIMATED
**Study First Submit Date:** 2007-11-26
**Study First Submit QC Date:** 2007-11-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Insel Gruppe AG, University Hospital Bern

#### Responsible Party

**Investigator Affiliation:** Insel Gruppe AG, University Hospital Bern

**Investigator Full Name:** Sebastian Wolf

**Investigator Title:** Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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®.

**Detailed 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.

### Conditions Module

**Conditions:**

- Age-Related Maculopathies

**Keywords:**

- age related macular degeneration

- supplementation

- macular pigment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** VitaluxPlus®

**Intervention Names:**

- Dietary Supplement: VitaluxPlus®

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Omega 3

**Intervention Names:**

- Dietary Supplement: Omega 3

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 1 tablet daily

**Name:** VitaluxPlus®

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** 1 tablet daily

**Name:** Omega 3

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** Macular pigment density

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** contrast sensitivity

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age related maculopathy

Exclusion Criteria:

* exudative age related degeneration

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bern

**Country:** Switzerland

**Facility:** Klinik und Poliklinik für Augenheilkunde, University Bern

#### Overall Officials

**Official 1:**

**Affiliation:** University of Bern

**Name:** Sebastian Wolf, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** University of Bern

**Name:** Ute Wolf-Schnurrbusch, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Wolf-Schnurrbusch UE, Zinkernagel MS, Munk MR, Ebneter A, Wolf S. Oral Lutein Supplementation Enhances Macular Pigment Density and Contrast Sensitivity but Not in Combination With Polyunsaturated Fatty Acids. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):8069-74. doi: 10.1167/iovs.15-17586.

**PMID:** 26720458

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11260

- Name: Macular Degeneration

- Relevance: HIGH

- As Found: Age-Related Maculopathy

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008268

- Term: Macular Degeneration

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: LOW

- As Found: Unknown

- ID: T407

- Name: Lutein

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
