Ocular Albinism (OA)LUVIANCT02200263
The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism
A study testing Lutein plus Zeaxanthin in people with Ocular Albinism (OA) and Oculocutaneous Albinism (OCA), run by Johns Hopkins University at 1 site in United States.
Trial summary
The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or oculocutaneous albinism. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ocular Albinism (OA), Oculocutaneous Albinism (OCA)
- What is being tested?
- Lutein plus Zeaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of 12 years old and older
- Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism
- Ocular media allowing acceptable visualization of the retina.
- Ocular media allowing acceptable quality of the ocular coherence tomography (OCT) and/or fundus autofluorescence (FAF) scans.
- At least one reliable central macular pigment optical density (MPOD) measurement captured on the enrollment visit in at least one eligible eye
- Best corrected visual acuity of 20/200 or better in one or both eligible eyes (eyes that confirmed to be eligible by the MPOD testing).
Who cannot join
- Persons taking lutein and/or zeaxanthin supplements over the past 6 months
- Pregnant or planning to become pregnant
- Evidence of present or past retinal macular condition other than congenital foveal hypoplasia
- History of gastrointestinal disease that would interfere with absorption of lutein and zeaxanthin
- Participation in a clinical trial requiring visual testing or administration of a drug (marketed or investigational) within 60 days before entry in the study (the day informed consent is signed)
- Inability to communicate or cooperate with the investigator due to cognitive impairment or poor general health
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute
Baltimore, Maryland, 21287-9277
About this study
Official title: A Randomized Placebo-controlled Trial to Investigate the Effect of Lutein and Zeaxanthin Supplementation on Macular Pigment and Visual Function in Albinism - LUtein for VIsion in Albinism (LUVIA)
The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo (no treatment) gel pill over the period of 12 months, with study visits approximately every 3 months for the first year and a final visit 18 months after enrollment.
Read the detailed description
Ocular and oculocutaneous albinism represent a spectrum of disorders with absent or significantly diminished amount of melanin either across different body tissues - skin, hair, eye (Oculocutaneous Albinism 1 and 2), or exclusively in eye tissues only (Ocular Albinism 1) .
The functionality and the clinical findings are diverse (the phenotype), and no direct correlation has been established to the underlying mutations (genotype).
The common ocular phenotype includes iris transillumination, foveal hypoplasia, nystagmus, reduced visual acuity, refractive error, photosensitivity and abnormal development of the visual pathways with characteristic abnormal routing of ganglion cell axons in the chiasma, resulting in abnormal visually evoked potentials. Current treatment options are limited to optical methods and low vision aids.
The mechanism of melanin pigment formation in the RPE cells and its role in the visual pathways and structures development is not completely understood, but a correlation was found between the amount of fundus pigmentation and visual function in albino patients. The absent pigmentation within the retinal pigment epithelium (RPE) may thus contribute to visual performance deficits.
The macular pigment (MP) consists of two main carotenoids, lutein and zeaxanthin, which are concentrated in the macular region of the retina. MP is hypothesized to function via a protective mechanism by absorbing blue light incident on the retina thereby reducing oxidative damage to the underlying photoreceptors. It is also thought to improve visual function via reduction of chromatic aberration and glare. It is currently unclear as to how the variability in macular pigment optical density (MPOD) affects congenital retinal conditions. The MP would, however, be a hypothetical and good candidate to improve visual performance - simply by increasing pigmentation, reducing light scatter and thus glare sensitivity.
As this pigment is not produced in the retina, but is absorbed via diet, it can be manipulated by alteration in diet and supplementation thereby providing potential therapy for retinal diseases. It is however necessary first to see if MPOD levels are measurable in this disorder before dietary advice can be provided after completion of the LUVIA study. Further to this, evaluation of both the structural and functional properties of the retina will provide greater insight into the possible function of MP in this retinal disease including whether supplementation would be of benefit.
- Being tested
- Lutein plus Zeaxanthin, Placebo
- Keywords
- ocular albinism (OA), oculocutaneous albinism (OCA), macular pigment, visual function
- Medical subject headings
- Albinism, Ocular, Albinism, Oculocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein plus ZeaxanthinDietary supplement
Also called EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)
dose: two softgels once a day with a meal
PlaceboDietary supplement
Also called placebo softgels
two softgels once-daily with a meal
| Study group | Role | What they receive |
|---|---|---|
| Lutein plus Zeaxanthin | Experimental | Participants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year. Receives: Dietary Supplement: Lutein plus Zeaxanthin |
| Placebo softgels | Placebo comparator | Participants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular pigment optical density (MPOD)
MPOD will be measured at baseline and follow-up. MPOD will be evaluated psychophysically using the QuantifEye device (ZeaVision), optically using the MPOD module of the Heidelberg Spectralis multicolor imaging device, and by quantitative fundus autofluorescence (FAF) using the Heidelberg Spectralis multicolor imaging device
Measured: 12 months
Secondary outcomes (5)
Contrast acuity
Contrast acuity will be measured at baseline and follow-up using the Innova electronic visual system and the quick Contrast Sensitivity Function (Adaptive Sensory Technology, LLC)
Measured: 12 months
Visual field, fixation and central retinal sensitivity
Microperimetry testing via the microperimetry (MP) -1 device (Nidek) will be performed at baseline and follow-up
Measured: 12 months
Bioavailability profile of Lutein and Zeaxanthin
Blood samples will be collected at follow-up, and Lutein and Zeaxanthin concentration levels assessed.
Measured: 12 months
Evaluation of the diversity of microstructural central retinal abnormalities
Spectral domain ocular coherence tomography (SD-OCT) macular scan will be performed at baseline and at 12 months
Measured: 12 months
Best Corrected Visual Acuity (BCVA)
BCVA will evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at baseline and follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Albinism (OA)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Clark Charitable Foundation Inc.
- Responsible party
- Sponsor
- Investigators
- Neil Bressler, MD, Principal investigator, Johns Hopkins UniversityMary E. Frey, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200263
- Sponsor's protocol ID
- NA_00088335
- Acronym
- LUVIA
- Status last verified
- Dec 2018
- First submitted
- 23 Jul 2014
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Trial to Investigate the Effect of Lutein and Zeaxanthin Supplementation on Macular Pigment and Visual Function in Albinism - LUtein for VIsion in Albinism (LUVIA)
- ClinicalTrials.gov ID
- NCT02200263
- Acronym / sponsor ID
- LUVIA / NA_00088335
- Keywords
- ocular albinism (OA), oculocutaneous albinism (OCA), macular pigment, visual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Clark Charitable Foundation Inc.
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 25 Jul 2014 (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 LUVIA study is a randomized placebo-controlled trial designed to investigate the effects of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo (no treatment) gel pill over the period of 12 months, with study visits approximately every 3 months for the first year and a final visit 18 months after enrollment.
Detailed description
Ocular and oculocutaneous albinism represent a spectrum of disorders with absent or significantly diminished amount of melanin either across different body tissues - skin, hair, eye (Oculocutaneous Albinism 1 and 2), or exclusively in eye tissues only (Ocular Albinism 1) .
The functionality and the clinical findings are diverse (the phenotype), and no direct correlation has been established to the underlying mutations (genotype).
The common ocular phenotype includes iris transillumination, foveal hypoplasia, nystagmus, reduced visual acuity, refractive error, photosensitivity and abnormal development of the visual pathways with characteristic abnormal routing of ganglion cell axons in the chiasma, resulting in abnormal visually evoked potentials. Current treatment options are limited to optical methods and low vision aids.
The mechanism of melanin pigment formation in the RPE cells and its role in the visual pathways and structures development is not completely understood, but a correlation was found between the amount of fundus pigmentation and visual function in albino patients. The absent pigmentation within the retinal pigment epithelium (RPE) may thus contribute to visual performance deficits.
The macular pigment (MP) consists of two main carotenoids, lutein and zeaxanthin, which are concentrated in the macular region of the retina. MP is hypothesized to function via a protective mechanism by absorbing blue light incident on the retina thereby reducing oxidative damage to the underlying photoreceptors. It is also thought to improve visual function via reduction of chromatic aberration and glare. It is currently unclear as to how the variability in macular pigment optical density (MPOD) affects congenital retinal conditions. The MP would, however, be a hypothetical and good candidate to improve visual performance - simply by increasing pigmentation, reducing light scatter and thus glare sensitivity.
As this pigment is not produced in the retina, but is absorbed via diet, it can be manipulated by alteration in diet and supplementation thereby providing potential therapy for retinal diseases. It is however necessary first to see if MPOD levels are measurable in this disorder before dietary advice can be provided after completion of the LUVIA study. Further to this, evaluation of both the structural and functional properties of the retina will provide greater insight into the possible function of MP in this retinal disease including whether supplementation would be of benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutein plus Zeaxanthin | Experimental | Dietary Supplement: Lutein plus ZeaxanthinParticipants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year. |
| Placebo softgels | Placebo comparator | Dietary Supplement: PlaceboParticipants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 12 years old and older
- Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism
- Ocular media allowing acceptable visualization of the retina.
- Ocular media allowing acceptable quality of the ocular coherence tomography (OCT) and/or fundus autofluorescence (FAF) scans.
- At least one reliable central macular pigment optical density (MPOD) measurement captured on the enrollment visit in at least one eligible eye
Key exclusion criteria (7 listed)
- Persons taking lutein and/or zeaxanthin supplements over the past 6 months
- Pregnant or planning to become pregnant
- Evidence of present or past retinal macular condition other than congenital foveal hypoplasia
- History of gastrointestinal disease that would interfere with absorption of lutein and zeaxanthin
- Participation in a clinical trial requiring visual testing or administration of a drug (marketed or investigational) within 60 days before entry in the study (the day informed consent is signed)
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 |
|---|---|---|
| Lutein plus ZeaxanthinAlso: EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)dose: two softgels once a day with a meal | Dietary supplement | Lutein plus Zeaxanthin |
| PlaceboAlso: placebo softgelstwo softgels once-daily with a meal | Dietary supplement | Placebo softgels |
Primary outcome
Macular pigment optical density (MPOD)
Time frame: 12 months
MPOD will be measured at baseline and follow-up. MPOD will be evaluated psychophysically using the QuantifEye device (ZeaVision), optically using the MPOD module of the Heidelberg Spectralis multicolor imaging device, and by quantitative fundus autofluorescence (FAF) using the Heidelberg Spectralis multicolor imaging device
5 secondary outcomes
Contrast acuity
Time frame: 12 months
Visual field, fixation and central retinal sensitivity
Time frame: 12 months
Bioavailability profile of Lutein and Zeaxanthin
Time frame: 12 months
Evaluation of the diversity of microstructural central retinal abnormalities
Time frame: 12 months
Best Corrected Visual Acuity (BCVA)
Time frame: 12 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 28 Dec 2018.
- Individual participant dataSharing planned: No
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.
Neil Bressler, MD principal investigator
Johns Hopkins University
Mary E. Frey study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein plus Zeaxanthin in people with Ocular Albinism (OA) and Oculocutaneous Albinism (OCA), run by Johns Hopkins University 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 6 inclusion and 7 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 28 Dec 2018. 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?
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 optical density (MPOD) (time frame: 12 months). 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 28 Dec 2018.