Clinical Trial: The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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)

Brief 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. 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 Summary:

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 conditi
Sponsor: Johns Hopkins University

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: July 23, 2014
Date Started: November 2014
Date Completion: September 2018
Last Updated: December 21, 2016
Last Verified: December 2016