Age Related Macular DegenerationNCT00993330
Macular Pigment Optical Density in Healthy Subjects
An observational study of Age Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- Healthy subjects without any signs of AMD
- Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
- Clear non-lenticular ocular media
- Visual acuity > 0.6
Who cannot join
- Any sign of AMD, or another retinal or optic nerve head disease
- Ocular surgery within the last 6 months
- Treatment with photosensitizing drugs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.
Furthermore the nutritional habits and the influence on MP density will be evaluated.
- Conditions
- Age Related Macular Degeneration
- Keywords
- macular pigment, to measure macular pigment in the retina
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 20 healthy subjects between 18 and 40 years | |
| 2 | 20 healthy subjects between 41 and 50 years | |
| 3 | 20 healthy subjects between 51 and 60 years | |
| 4 | 20 healthy subjects between 61 and 70 years | |
| 5 | 20 healthy subjects between 71 and 80 years | |
| 6 | 20 healthy subjects between 81 and 90 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPOD as measured with optical reflectometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhofer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993330
- Sponsor's protocol ID
- OPHT-310109
- Status last verified
- Nov 2014
- First submitted
- 9 Oct 2009
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Pigment Optical Density in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00993330
- Acronym / sponsor ID
- OPHT-310109
- Conditions
- Age Related Macular Degeneration
- Keywords
- macular pigment, to measure macular pigment in the retina
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Oct 2009 (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 macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.
Furthermore the nutritional habits and the influence on MP density will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –20 healthy subjects between 18 and 40 years |
| 2 | – | –20 healthy subjects between 41 and 50 years |
| 3 | – | –20 healthy subjects between 51 and 60 years |
| 4 | – | –20 healthy subjects between 61 and 70 years |
| 5 | – | –20 healthy subjects between 71 and 80 years |
| 6 | – | –20 healthy subjects between 81 and 90 years |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (4 listed)
- Healthy subjects without any signs of AMD
- Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
- Clear non-lenticular ocular media
- Visual acuity > 0.6
Key exclusion criteria (3 listed)
- Any sign of AMD, or another retinal or optic nerve head disease
- Ocular surgery within the last 6 months
- Treatment with photosensitizing drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MPOD as measured with optical reflectometry
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Gerhard Garhofer, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Nov 2014. 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 Austria. 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 was stopped early. Results are not available in the source record.
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?
MPOD as measured with optical reflectometry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2014.