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Macular Pigment and Visual Performance in Glaucoma Patients

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ClinicalTrials.gov Identifier: NCT03959592
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Heidelberg Engineering GmbH
MacuHealth LP
Industrial Orgánica S.A. de C.V.
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Lutein, zeaxanthin and mesozeaxanthin Other: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Macular Pigment and Visual Performance in Glaucoma Patients
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Lutein

Arm Intervention/treatment
Active Comparator: Lutein, zeaxanthin and mesozeaxanthin
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain 22 mg total of the carotenoids lutein (10 mg), zeaxanthin (2 mg), and mesozeaxanthin (10 mg).
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 Name: macular carotenoids

Placebo Comparator: Placebo
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Other: Placebo
This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.




Primary Outcome Measures :
  1. Change in the Contrast sensitivity [ Time Frame: Measures of contrast sensitivity will be conducted at baseline, 3, and 6 months after the start of the trial. ]
    Ability of the patient to discern faint borders that mark the boundary between relatively dark and light areas

  2. Change in the Macular pigment optical density [ Time Frame: Measures of macular pigment optical density at baseline, 3, and 6 months after the start of the trial. ]
    Accumulation of the macular carotenoids (lutein, zeaxanthin, and mesozeaxanthin) occurs in the central retina, and is characterized by its optical density (the ability of the pigment to absorb light).


Secondary Outcome Measures :
  1. Change in the Speed of dark adaptation [ Time Frame: The investigators plan to assess the time it takes to visually adapt to a standard level at baseline, and 6 months after the start of the trial. ]
    After exposure to a relatively bright environment, visual adaptation to the dark (where one can reliably detect objects in dim light) takes some time.

  2. Change in Vision in glare [ Time Frame: Measures of contrast sensitivity in the presence of glare will be conducted at baseline and 6 months after the start of the trial. ]
    Visual performance, especially contrast sensitivity, is greatly decreased by the presence of glare.

  3. Change in the quality of life by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: The investigators plan to administer the VFQ-25 at baseline, and 6 months after the start of the trial. ]
    The NEI VFQ-25 is a 25-question visual function quality questionnaire. Values are assigned from 0 to 100 according to the answers to 25 items. Higher values represent a better outcome.

  4. Visual field assessment [ Time Frame: Visual fields will be assessed at baseline, and 6 months after the start of the trial. ]
    A visual field assessment tests the sensitivity of regions across the retina that correspond to points in the visual field.

  5. Change in the Point-spread function [ Time Frame: Measures of the point-spread function will be obtained at baseline and 6 months after the start of the trial. ]
    The point-spread function describes the optical quality of the eye.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • glaucoma diagnosis: To be considered glaucomatous, patients will be required to have: (1) history of elevated intraocular pressure (IOP; over 21 mmHg); (2) at least two consecutive and reliable standard automated perimetry (SAP) examinations with either a pattern standard deviation (PSD) outside the 95% normal limits or a glaucoma hemifield test (GHT) result outside the 99% normal limits; and/or glaucomatous optic neuropathy.
  • between the ages of 18 and 75 years,
  • must be able and willing to provide signed informed consent and follow study instructions.

Exclusion Criteria:

  • no systemic disease, no other ocular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959592


Contacts
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Contact: Eric Cabezas, BS 16192009490 eric.cabezas@duke.edu
Contact: James M Stringham, PhD 12102044189 james.stringham@duke.edu

Locations
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United States, North Carolina
Duke University Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Eric Cabezas    919-684-9291    eric.cabezas@duke.edu   
Principal Investigator: Felipe A Medeiros, PhD         
Sub-Investigator: James M Stringham, PhD         
Sponsors and Collaborators
Duke University
Heidelberg Engineering GmbH
MacuHealth LP
Industrial Orgánica S.A. de C.V.
Investigators
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Principal Investigator: Felipe A Medeiros, MD, PhD Duke Eye Center

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03959592     History of Changes
Other Study ID Numbers: Pro00093041
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs