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

Completed · Not applicable · Has a placebo group

Conditions studied: Ocular Albinism (OA), Oculocutaneous Albinism (OCA)

In brief

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.

Key facts

Study ID

NCT02200263

Run by

Johns Hopkins University

People needed

10

Starts

2014-11-01

Expected to finish

2018-04-01

Last updated by the study team

2018-12-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Wilmer Eye Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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