Ocular Albinism (OA) Clinical Trial
— LUVIAOfficial 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)
NCT number | NCT02200263 |
Other study ID # | NA_00088335 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | April 2018 |
Verified date | December 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wilmer Eye Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Clark Charitable Foundation Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macular pigment optical density (MPOD) | 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 | 12 months | |
Secondary | Contrast acuity | 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) | 12 months | |
Secondary | Visual field, fixation and central retinal sensitivity | Microperimetry testing via the microperimetry (MP) -1 device (Nidek) will be performed at baseline and follow-up | 12 months | |
Secondary | Bioavailability profile of Lutein and Zeaxanthin | Blood samples will be collected at follow-up, and Lutein and Zeaxanthin concentration levels assessed. | 12 months | |
Secondary | Evaluation of the diversity of microstructural central retinal abnormalities | Spectral domain ocular coherence tomography (SD-OCT) macular scan will be performed at baseline and at 12 months | 12 months | |
Secondary | Best Corrected Visual Acuity (BCVA) | BCVA will evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at baseline and follow-up | 12 months |