An exploratory study evaluating the effects of macular carotenoid supplementation in various retinal diseases

Figures & data

Table 1 Baseline demographics of the study participants

Variables	Data
Number of patients (eyes), n	49 (49)
Sex, n (%)
Males	23 (46.9)
Females	26 (53.1)
Age (years), mean (SD)	59.4±13.6
Ethnicity, n (%)
Asian or Asian British	12 (24.5)
Black or Black British	3 (6.1)
White or White British	34 (69.4)
Diabetes, n (%)	26 (53.1)
Type 1	3 (11.5)
Type 2	23 (88.5)
BMI (kg/m^2), mean (SD)	28.8±6.1
HbA1c (%), mean (SD) in diabetic population	8.3±1.9
Systolic BP (mmHg), mean (SD)	134.9±17.3
Diastolic BP (mmHg), mean (SD)	83±13.2
Retinal diseases, N (%)
Normal	4 (8.2)
Diabetic retinopathy
DR with no macular edema	10 (20.4)
DR with macular edema	10 (20.4)
Early ARM	12 (24.5)
AMD	8 (16.3)
CSR	5 (10.2)
BCVA (ETDRS letters), mean (SD)	83.2±7.6

Abbreviations: AMD, age-related macular degeneration; ARM, age-related maculopathy; BCVA, best corrected visual acuity; BMI, body mass index; BP, blood pressure; CSR, central serous retinopathy; DR, diabetic retinopathy; ETDRS, Early Treatment of Diabetic Retinopathy Study; HbA1c, glycated hemoglobin.

Table 2 Change in macular pigment optical density and total macular pigment complement using the DWAF

Parameter	Baseline, mean (SD)	3 months mean (SD)	Change in 0–3 months, mean (SD)	P-value	6 months, mean (SD)	Change in 0–6 months, mean (SD)	P-value
Macular pigment optical density: n =49
DWAF optical density 0.5 with 7° reference	0.31±0.25	0.39±0.26	0.081±0.26	0.31	0.39±0.27	0.082±0.274	0.041
Macular pigment volume: n =49
DWAF volume with 10.5° reference	3,466.7±3,179.3	5,048.5±3,376.6	1,581.8±3,627.1	0.004	5,791.1±4,110.0	2,324.3±4,134.1	,0.001

Notes: Results are in response to an analysis of variance; significant P-values are those <0.05.

Abbreviation: DWAF, dual-wavelength autofluorescence.

Figure 1 Averaged MPOD profiles in patients at baseline per retinal disease.

Abbreviations: AMD, age-related macular degeneration; ARM, age-related maculopathy; CSR, central serous retinopathy; DR, diabetic retinopathy; MPOD, macular pigment optical density.

Figure 2 Averaged MPOD profiles in patients at 6 months post-supplementation per retinal disease.

Abbreviations: AMD, age-related macular degeneration; ARM, age-related maculopathy; CSR, central serous retinopathy; DR, diabetic retinopathy; MPOD, macular pigment optical density.

Table 3 Change in contrast sensitivity measurements in various conditions

Spatial frequency (cycles)	Baseline, mean (SD)	3 months, mean (SD)	Change in 0–3 months, mean (SD)	P-value	6 months, mean (SD)	Change in 0–6 months, mean (SD)	P-value
Night testing with glare
1.5	18.6±19.4	33.3±27.9	14.7±26.5	0.001	37.5±25.7	18.9±23.7	<0.00
3	33.2±25.8	56.3±34.9	23.2±36.5	0.002	58.9±39.0	25.7±36.1	0.001
6	25.3±18.9	55.5±52.4	30.2±46.0	0.003	48.5±40.7	24.3±36.3	0.002
12	7.1±4.3	15.9±17.8	8.8±16.7	0.053	17.2±15.6	9.8±15.9	0.047
18	2.8±1.1	4.0±4.5	1.2±3.9	0.529	3.2±2.7	0.4±1.6	1.00
Night testing without glare
1.5	40.4±31.2	56.6±33.0	16.2±27.9	<0.001	65.2±30.6	24.7±31.7	<0.001
3	47.7±32.0	74.8±45.8	27.1±37.2	<0.001	81.3±45.6	33.6±48.6	<0.001
6	39.2±33.2	59.6±44.5	20.4±31.2	<0.001	74.3±59.0	34.6±48.6	<0.001
12	9.2±7.3	19.8±20.7	10.6±17.3	0.004	23.9±26.7	15.0±23.0	0.002
18	3.8±3.6	7.1±5.3	3.4±5.1	0.103	9.3±6.9	4.7±6.5	0.065
Day testing with glare
1.5	36.9±25.9	52.4±30.5	15.5±24.8	<0.001	51.7±28.7	14.8±29.5	0.002
3	56.6±34.8	84.1±41.1	27.5±35.7	<0.001	83.3±42.8	28.5±41.8	<0.001
6	56.6±34.8	81.4±51.6	24.7±43.3	0.001	88.4±58.1	32.5±51.3	<0.001
12	26.0±22.5	33.0±27.0	7.0±20.1	0.05	39.6±35.1	14.9±30.4	0.008
18	10.3±7.2	15.4±17.2	5.0±13.1	0.078	14.3±13.1	4.5±10.2	0.036
Day testing without glare
1.5	36.7±24.6	52.0±28.2	15.2±24.8	<0.001	57.0±31.3	20.1±30.9	<0.001
3	53.6±31.8	77.6±2.85	24.0±33.8	<0.001	85.9±49.4	32.2±44.5	<0.001
6	62.9±49.8	86.3±55.3	23.4±35.7	<0.001	90.3±59.4	27.1±44.5	<0.001
12	27.8±23.1	42.7±35.4	14.9±22.2	0.001	53.0±42.7	25.9±34.5	<0.001
18	8.9±7.7	13.0±14.4	4.1±11.3	0.071	14.0±11.3	4.9±10.4	0.022

Notes: Results are in response to an analysis of variance; significant P-values are those <0.05.

Table 4 Change in the quality of life as measured by NEI-VFQ-25²⁰ and EQ-5D³⁹

Parameters	Baseline, mean (SD)	3 months, mean (SD)	Change in 0–3 months, mean (SD)	P-value	6 months, mean (SD)	Change in 0–6 months, mean (SD)	P-value
Vision-related quality of life
NEI-VFQ-25 composite	84.8±14.5	87.8±11.9	3.04±6.98	0.005	89.3±11.5	3.58±7.11	0.002
Effect size				0.23			0.34
Subscales
General health	62.2±23.6	60.6±19.6	−1.7±17.8	0.538	58.9±19.3	−3.3±17.4	0.204
General vision	70.2±19.4	74.2±17.9	4.0±13.9	0.060	76.0±15.7	3.1±14.7	0.164
Ocular pain	84.2±16.1	86.4±16.0	2.2±14.7	0.315	87.8±14.0	3.6±13.5	0.079
Near activities	80.6±21.5	83.1±19.0	2.3±11.9	0.151	87.5±18.9	5.6±10.3	0.001
Effect size							0.34
Distance activities	85.3±18.2	88.2±16.1	3.0±8.7	0.028	89.0±16.9	3.7±10.0	0.017
Effect size				0.17			0.28
Social functioning	93.3±915.2	95.3±11.7	1.9±8.4	0.128	95.6±11.0	1.9±7.5	0.090
Mental health	80.0±21.3	86.3±12.5	6.3±14.7	0.006	87.1±14.8	5.3±11.5	0.003
Effect size				0.36			0.39
Role difficulties	80.3±22.4	84.2±20.5	3.9±19.7	0.193	86.7±19.1	5.3±17.0	0.043
Dependency	94.6±15.0	95.2±11.0	0.6±10.7	0.730	95.9±10.1	0.6±9.6	0.701
Driving	90.3±17.0	92.7±16.0	2.3±8.2	0.166	93.0±16.3	3.3±9.0	0.076
Color vision	93.3±16.3	95.0±12.6	1.7±15.4	0.473	97.2±9.6	2.2±14.9	0.323
Peripheral vision	85.6±23.5	90.6±16.2	5.0±16.5	0.048	90.6±16.2	5.0±18.2	0.071
Effect size				0.25
Quality of life – overall health score index
EQ-5D	0.89±0.13	0.89±0.13	0.005±0.083	0.706	0.92±0.13	0.032±0.096	0.034
Effect size							0.23

Notes: Results are in response to an analysis of variance; significant P-values are those <0.05.

Abbreviation: EQ-5D, EuroQoL-5 dimension.

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