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Macular Pigment and Visual Performance in Glaucoma Patients

NCT03959592 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-01-03

Study results available
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Summary

The purpose of this study is to determine cross-sectional relationships between macular pigment optical density (MPOD) and visual performance in glaucoma. Additionally, the investigators wish to determine the effect of lutein, zeaxanthin, and mesozeaxanthin supplementation on MPOD and visual performance in glaucoma patients.

Conditions

Interventions

DRUG

Lutein, zeaxanthin and mesozeaxanthin

The intervention will involve supplementation with the macular carotenoids (1 pill daily with a meal containing lutein, zeaxanthin, mesozeaxanthin) for six months, to determine the effects on visual performance in glaucoma patients.

OTHER

Placebo

This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.

Sponsors & Collaborators

  • Heidelberg Engineering GmbH

    collaborator INDUSTRY

  • MacuHealth

    collaborator INDUSTRY

  • Industrial Orgánica S.A. de C.V.

    collaborator INDUSTRY

  • Felipe Medeiros, MD

    lead OTHER

Principal Investigators

  • Felipe A Medeiros, MD, PhD · Duke Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2021-11-09
Completion
2021-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959592 on ClinicalTrials.gov