Status:
COMPLETED
The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Clark Charitable Foundation Inc.
Conditions:
Ocular Albinism (OA)
Oculocutaneous Albinism (OCA)
Eligibility:
All Genders
12+ years
Phase:
NA
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...
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 Al...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02200263
Start Date
November 1 2014
End Date
April 1 2018
Last Update
December 28 2018
Active Locations (1)
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1
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9277