CompletedNot Applicable

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

United States10 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Macular pigment optical density (MPOD)

Timeframe: 12 months

Trial details

NCT IDNCT02200263

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Ocular Albinism (OA) trials