Macular Pigment and Visual Performance in Glaucoma Patients
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|ClinicalTrials.gov Identifier: NCT03959592|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : December 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Lutein, zeaxanthin and mesozeaxanthin Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled trial|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Macular Pigment and Visual Performance in Glaucoma Patients|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
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).
This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
- 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
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Eric Cabezas, BSemail@example.com|
|Contact: James M Stringham, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Eye Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Eric Cabezas 919-684-9291 email@example.com|
|Principal Investigator: Felipe A Medeiros, PhD|
|Sub-Investigator: James M Stringham, PhD|
|Principal Investigator:||Felipe A Medeiros, MD, PhD||Duke Eye Center|