Vision, EntopticMP-GDNCT00909090
Macular Pigment and Glare Disability
A study testing 12 mg Lutein + Zeaxanthin in people with Vision, Entoptic, run by University of Georgia at 1 site in United States.
Trial summary
The purpose of this study is: I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months. II. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision, Entoptic
- What is being tested?
- 12 mg Lutein + Zeaxanthin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: male or female
- Age: 18 - 40 years
- BMI: 20-30
- No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- No anticipated surgical procedures.
- Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
- Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- Corrected visual acuity (ETDRS): better than 20/60
Who cannot join
- BMI <20 or >30
- Age <18 or >40 years
- Smokers
- Current or history of relevant diseases (such as AMD)
- Corrected visual acuity worse than 20/60
- Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
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- Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
- Current use of xanthophyll containing supplements
- Use of xanthophyll containing supplements in the past 6 months
- Participation in any other study during last 1 month.
- Blood donation during the last 3 months.
- Known hypersensitivity or allergy to xanthophylls.
- Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
- Suspected lack of compliance with any requirements of the study.
- Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
- Current pregnancy or breast feeding
- Any relevant abnormalities in the routine laboratory tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Sciences Laboratory, UGA
Athens, Georgia, 30602
About this study
Official title: Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
The purpose of this study is:
- To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.
II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.
III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.
IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
Read the detailed description
The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:
Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.
- Conditions
- Vision, Entoptic
- Being tested
- 12 mg Lutein + Zeaxanthin, Visually identical placebo
- Keywords
- macular pigment, glare disability, lutein, photostress, chromatic contrast sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mg Lutein + ZeaxanthinDietary supplement
Also called FloraGlo lutein + OptiSharp zeaxanthin
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year
Visually identical placeboDietary supplement
Visually identical placebo, taken once daily for one year
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Receives: Dietary Supplement: 12 mg Lutein + Zeaxanthin |
| Placebo | Placebo comparator | visually identical placebo Receives: Dietary Supplement: Visually identical placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density
optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity
Measured: every three months for one year; 12-month measure reported.
Secondary outcomes (3)
Glare Disability
light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
Measured: 12-month data point only
Photostress Recovery Time
amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target
Measured: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
Heterochromatic Contrast Sensitivity
amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
Measured: 12-month data point only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vision, EntopticStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms: nutritional supplement vs. placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Billy R. Hammond, University of Georgia
- Investigators
- Billy R Hammond, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909090
- Sponsor's protocol ID
- UGA-2009-10141-1
- Acronym
- MP-GD
- Status last verified
- Jun 2020
- First submitted
- 22 May 2009
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammond BR, Fletcher LM, Roos F, Wittwer J, Schalch W. A double-blind, placebo-controlled study on the effects of lutein and zeaxanthin on photostress recovery, glare disability, and chromatic contrast. Invest Ophthalmol Vis Sci. 2014 Dec 2;55(12):8583-9. doi: 10.1167/iovs.14-15573.
PubMed 25468896Hammond BR Jr, Fletcher LM, Elliott JG. Glare disability, photostress recovery, and chromatic contrast: relation to macular pigment and serum lutein and zeaxanthin. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):476-81. doi: 10.1167/iovs.12-10411.
PubMed 23211814
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00909090
- Acronym / sponsor ID
- MP-GD / UGA-2009-10141-1
- Conditions
- Vision, Entoptic
- Keywords
- macular pigment, glare disability, lutein, photostress, chromatic contrast sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.
II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.
III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.
IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
Detailed description
The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:
Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms: nutritional supplement vs. placebo.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: 12 mg Lutein + Zeaxanthin10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin |
| Placebo | Placebo comparator | Dietary Supplement: Visually identical placebovisually identical placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Gender: male or female
- Age: 18 - 40 years
- BMI: 20-30
- No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- No anticipated surgical procedures.
Key exclusion criteria (17 listed)
- BMI <20 or >30
- Age <18 or >40 years
- Smokers
- Current or history of relevant diseases (such as AMD)
- Corrected visual acuity worse than 20/60
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 |
|---|---|---|
| 12 mg Lutein + ZeaxanthinAlso: FloraGlo lutein + OptiSharp zeaxanthin10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | Dietary supplement | Intervention |
| Visually identical placeboVisually identical placebo, taken once daily for one year | Dietary supplement | Placebo |
Primary outcome
Macular Pigment Optical Density
Time frame: every three months for one year; 12-month measure reported.
optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity
3 secondary outcomes
Glare Disability
Time frame: 12-month data point only
Photostress Recovery Time
Time frame: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
Heterochromatic Contrast Sensitivity
Time frame: 12-month data point only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25468896Hammond BR, Fletcher LM, Roos F, Wittwer J, Schalch W. A double-blind, placebo-controlled study on the effects of lutein and zeaxanthin on photostress recovery, glare disability, and chromatic contrast. Invest Ophthalmol Vis Sci. 2014 Dec 2;55(12):8583-9. doi: 10.1167/iovs.14-15573.
- Derived from this study: PubMed 23211814Hammond BR Jr, Fletcher LM, Elliott JG. Glare disability, photostress recovery, and chromatic contrast: relation to macular pigment and serum lutein and zeaxanthin. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):476-81. doi: 10.1167/iovs.12-10411.
- Individual participant dataSharing planned: No
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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.
Billy R Hammond, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 mg Lutein + Zeaxanthin in people with Vision, Entoptic, run by University of Georgia at 1 site in United States.
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 8 inclusion and 17 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 13 Jul 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Optical Density (time frame: every three months for one year; 12-month measure reported.). 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 NCT00909090, 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 13 Jul 2020.