The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism (LUVIA)
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|ClinicalTrials.gov Identifier: NCT02200263|
Recruitment Status : Recruiting
First Posted : July 25, 2014
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ocular Albinism (OA) Oculocutaneous Albinism (OCA)||Dietary Supplement: Lutein plus Zeaxanthin Dietary Supplement: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Lutein plus Zeaxanthin
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.
Dietary Supplement: Lutein plus Zeaxanthin
dose: two softgels once a day with a meal
Other Name: EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)
Placebo Comparator: Placebo softgels
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
Dietary Supplement: Placebo
two softgels once-daily with a meal
Other Name: placebo softgels
- 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
- Contrast acuity [ Time Frame: 12 months ]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)
- Visual field, fixation and central retinal sensitivity [ Time Frame: 12 months ]Microperimetry testing via the microperimetry (MP) -1 device (Nidek) will be performed at baseline and follow-up
- Bioavailability profile of Lutein and Zeaxanthin [ Time Frame: 12 months ]Blood samples will be collected at follow-up, and Lutein and Zeaxanthin concentration levels assessed.
- Evaluation of the diversity of microstructural central retinal abnormalities [ Time Frame: 12 months ]Spectral domain ocular coherence tomography (SD-OCT) macular scan will be performed at baseline and at 12 months
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]BCVA will evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at baseline and follow-up
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200263
|Contact: Mary Freyemail@example.com|
|United States, Maryland|
|Wilmer Eye Institute||Recruiting|
|Baltimore, Maryland, United States, 21287-9277|
|Contact: Mary E. Frey 443-287-7912 firstname.lastname@example.org|
|Sub-Investigator: Mary Frey|
|Principal Investigator: Neil Bressler, MD|
|Principal Investigator:||Neil Bressler, MD||Johns Hopkins University|
|Study Director:||Mary E. Frey||Johns Hopkins University|