Trial Outcomes & Findings for Macular Pigment and Visual Performance in Glaucoma Patients (NCT NCT03959592)
NCT ID: NCT03959592
Last Updated: 2023-01-03
Results Overview
Contrast sensitivity is the ability to detect subtle differences in shading and patterns. In temporal contrast sensitivity, a spatially homogeneous disc whose luminance varies sinusoidally over time is presented. Its temporal frequency is measured as the maximum number of cycles in a second (Hz) at which the flickering is perceived by the patient.
TERMINATED
PHASE1/PHASE2
8 participants
Baseline to 6 months
2023-01-03
Participant Flow
Participant milestones
| Measure |
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).
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.
|
Placebo
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Macular Pigment and Visual Performance in Glaucoma Patients
Baseline characteristics by cohort
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=3 Participants
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).
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.
|
Placebo
n=5 Participants
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 3.2 • n=99 Participants
|
61.8 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
67.1 years
STANDARD_DEVIATION 3.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Eyes with low visual acuity were excluded from the analysis.
Contrast sensitivity is the ability to detect subtle differences in shading and patterns. In temporal contrast sensitivity, a spatially homogeneous disc whose luminance varies sinusoidally over time is presented. Its temporal frequency is measured as the maximum number of cycles in a second (Hz) at which the flickering is perceived by the patient.
Outcome measures
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=4 Eyes
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).
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.
|
Placebo
n=7 Eyes
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Change in Contrast Sensitivity
|
3.44 Hz
Standard Deviation 4.83
|
-0.23 Hz
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants excluded from this analysis if presenting low signal quality due to media opacity.
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). Optical density equals the log to the base 10 of the reciprocal of the transmittance.
Outcome measures
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=3 Eyes
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).
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.
|
Placebo
n=2 Eyes
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Change in the Macular Pigment Optical Density
|
0.06 Optical density units
Standard Deviation 0.06
|
0.02 Optical density units
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Data not collected.
After exposure to a relatively bright environment, visual adaptation to the dark (where one can reliably detect objects in dim light) takes some time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Patients excluded from this analysis if not able to see letter at 100% contrast with glare on in at least one of the visits.
Visual performance, especially contrast sensitivity, is greatly decreased by the presence of glare. Range 0% (white on white) to 100% (black on white) contrast.
Outcome measures
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=1 Eyes
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).
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.
|
Placebo
n=1 Eyes
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Change in Vision in Glare as Measured by Percentage of Contrast
|
0 percentage of contrast
|
48 percentage of contrast
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: One subject in the placebo group did not respond to the NEI VFQ-25 at the 6 month visit.
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.
Outcome measures
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=3 Participants
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).
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.
|
Placebo
n=4 Participants
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Change in the Quality of Life by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
|
11.2 score on a scale
Standard Deviation 10.8
|
11.0 score on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Eyes with visual fields with low reliability score were excluded from the analysis.
A visual field assessment tests the sensitivity of regions across the retina that correspond to points in the visual field. Mean deviation (MD) reflects the overall depression (deviation from normal values) of the field in dB.
Outcome measures
| Measure |
Lutein, Zeaxanthin and Mesozeaxanthin
n=4 Eyes
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).
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.
|
Placebo
n=7 Eyes
Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).
Placebo: This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
|
|---|---|---|
|
Change in Visual Field Assessment
|
0.06 dB
Standard Deviation 0.59
|
-0.36 dB
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Data not collected.
The point-spread function describes the optical quality of the eye.
Outcome measures
Outcome data not reported
Adverse Events
Lutein, Zeaxanthin and Mesozeaxanthin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place