Age-Related MaculopathiesEMPOLSNCT00563979
Enhancement of Macular Pigment Density by Oral Lutein Supplementation
A study testing VitaluxPlus® and Omega 3 in people with Age-Related Maculopathies, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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®. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Maculopathies
- What is being tested?
- VitaluxPlus® and Omega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age related maculopathy
Who cannot join
- exudative age related degeneration
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern
About this study
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®.
Read the 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
- Age-Related Maculopathies
- Being tested
- VitaluxPlus®, Omega 3
- Keywords
- age related macular degeneration, supplementation, macular pigment
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaluxPlus®Dietary supplement
1 tablet daily
Omega 3Dietary supplement
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | VitaluxPlus® Receives: Dietary Supplement: VitaluxPlus® |
| 2 | Active comparator | Omega 3 Receives: Dietary Supplement: Omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular pigment density
Measured: 6 months
Secondary outcomes (1)
contrast sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-Related MaculopathiesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Wolf, Insel Gruppe AG, University Hospital Bern
- Investigators
- Sebastian Wolf, MD, Study director, University of BernUte Wolf-Schnurrbusch, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563979
- Sponsor's protocol ID
- KEK 152/07
- Acronym
- EMPOLS
- Status last verified
- Jun 2015
- First submitted
- 26 Nov 2007
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PubMed 37702300Wolf-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.
PubMed 26720458
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Macular Pigment Density by Oral Lutein Supplementation
- ClinicalTrials.gov ID
- NCT00563979
- Acronym / sponsor ID
- EMPOLS / KEK 152/07
- Conditions
- Age-Related Maculopathies
- Keywords
- age related macular degeneration, supplementation, macular pigment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: VitaluxPlus®VitaluxPlus® |
| 2 | Active comparator | Dietary Supplement: Omega 3Omega 3 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age related maculopathy
Key exclusion criteria (1 listed)
- exudative age related degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaluxPlus®1 tablet daily | Dietary supplement | 1 |
| Omega 31 tablet daily | Dietary supplement | 2 |
Primary outcome
Macular pigment density
Time frame: 6 months
1 secondary outcome
contrast sensitivity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Derived from this study: PubMed 37702300Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
- Derived from this study: PubMed 26720458Wolf-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Wolf, MD study director
University of Bern
Ute Wolf-Schnurrbusch, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaluxPlus® and Omega 3 in people with Age-Related Maculopathies, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular pigment density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.