Demographics and Clinical Characteristics
As Table 1 shows, 142 patients with a mean age of 63.49 (SD = 11.07) years were recruited at baseline before their treatment; nearly half (48.59%) were male; the majority (80.28%) were from urban areascompared with 19.72% from rural areas; more than half (56.34%) had a monthly incomeless than 10,000 RMB; 69.01%were married; 40.85% had tertiary or higher education, and 23.24% had primary or lower education.
In clinical characteristics, 68.31% had only one eye affected by exudative AMD. The mean visual acuity in the treated eye was 0.29 (SD=0.03), while the mean of best-corrected visual acuity was 0.51 (SD = 0.12). A total of 137 patients were available for follow-up at 1 month, 131 patients were available for 3-month follow-up, 128 for 6-month follow-up, and 115 patients were available for follow-up at twelve-month. Sixteen patients dropped out during follow-up examinationsbecause they elected to continue treatment elsewhere. Their absence created no differences in age, sex, education, marital status, area of residence, income, or visual acuity at baseline from those who participated in follow-ups.
Table 1 Demographics and clinical characteristics of the patients at baseline and follow-ups
Demographic and clinical features
|
Number (percentage) Or Mean±SD
|
Baseline(N=142)
|
1 Month(N=137)
|
3 Months(N=131)
|
6 Months(N=128)
|
12 Months(N=115)
|
Age, years (Mean ± SD)
|
63.49±11.07
|
63.47±12.11
|
64.09±18.43
|
62.89±7.31
|
63.66±10.03
|
Gender
Male
Female
|
69 (48.59%)
73 (51.41%)
|
67 (48.91%)
70 (51.09%)
|
63 (48.09%)
68 (51.91%)
|
62 (48.44%)
66 (51.56%)
|
55 (48.59%)
60 (51.41%)
|
Education
Primary or lower
Secondary
Tertiary or higher
|
33 (23.24%)
51 (35.92%)
58 (40.85%)
|
32 (23.36%)
47 (34.31%)
58 (42.34%)
|
30 (22.90%)
45 (34.35%)
56 (42.75%)
|
29 (22.66%)
45 (35.16%)
54 (42.19%)
|
24 (20.87%)
39 (33.91%)
52 (45.22%)
|
Marital status
Married
Not currently married
|
98 (69.01%)
44 (30.99%)
|
96 (70.07%)
41 (29.93%)
|
97 (74.05%)
34 (25.95%)
|
95 (74.22%)
33 (25.78%)
|
93 (80.87%)
22 (19.13%)
|
Area of residence
Urban
Rural
|
114 (80.28%)
28 (19.72%)
|
114(83.21%)
23 (16.79%)
|
109 (83.21%)
22 (16.79%)
|
106 (82.81%)
22 (17.19%)
|
94 (81.74%)
21 (18.26%)
|
Income
≥10,000RMB/month
<10,000RMB/month
|
62 (43.66%)
80 (56.34%)
|
57(41.61%)
80 (58.39%)
|
56 (42.75%)
75 (57.25%)
|
55 (42.97%)
73 (57.03%)
|
45 (39.13%)
70 (60.87%)
|
Eye affected by AMD
Unilateral cases
|
112 (68.31%)
|
109 (79.56%)
|
107 (81.68%)
|
106 (82.81%)
|
93 (80.87%)
|
Bilateral cases
|
30 (31.69%)
|
28 (20.44%)
|
24 (18.32%)
|
22 (17.19%)
|
22 (19.13%)
|
VA treated eye
|
0.29±0.03
|
0.32±0.02
|
0.38±0.11
|
0.41±0.18
|
0.40±0.19
|
BCVA
|
0.51±0.12
|
0.48±0.03
|
0.58±0.07
|
0.62±0.21
|
0.58±0.16
|
No. of intravitreal injections
|
|
1.02±0.15
|
3.07±0.25
|
3.80±0.76
|
4.70±0.85
|
Changes in Quality of Life over Time
The mean scores of overall scales and subscales at baseline and follow-up are presented in Figure 1. Comparing the scores at baseline, statistically significant differences were found inthree NEI VFQ-25 subscales—general vision, dependency, and driving—at 1-month follow-up after anti-VEGF treatment forAMD; in the scores for six NEI VFQ-25 subscales—general health, general vision, near activities, role difficulties, dependency, and driving—at3-month follow-up; inscores for nine NEI VFQ-25 subscales—total score, general health, general vision, near activities, social functioning, role difficulties, driving, colour vision, and peripheral vision—at 6- month follow-up; and in the scores for six NEI VFQ-25 subscales—general vision, distance activities, social functioning, role difficulties, dependency, and driving—at the 12-month follow-up.
All the data were normally distributed; therefore, univariate analyses with t-test or Pearson’s correlation coefficient were performed to find factors that couldpredict HRQoL (Tables 2 and 3 and Supplementary Table 1). At baseline, the categorical variables marital status (t=5.778, P<0.001), area of residence (t=2.90, P=0.004), income (t=8.06, P<0.001),and eye affected by AMD (t=3.095,P=0.002)were found statistically significant between the t-tested groups. The continuous variables negative coping (r= –0.259, P<0.01), depression (r= –0.270,P<0.01), VA treatedeye (r=0.409,P<0.01), and BCVA (r=0.680,P<0.01) correlated significantly with the total score of NEI VFQ-25.
At the 1-month follow-up, the categorical variables gender (t=2.092,P=0.038), income (t=6.811,P<0.001), and eye affected by AMD (t=3.260,P=0.001) were found statistically significant between the t-tested groups. The continuous variablesanxiety (r= –0.537,P<0.01), depression(r= –0.533, P<0.01), self-efficacy(r=0.272,P<0.01), VA treated eye (r=0.231,P<0.01), and BCVA (r=0.419,P<0.01) correlated significantly with the total score of NEI VFQ-25.
At the 3-month follow-up, the categorical variables gender (t=2.884,P=0.005), education(t=7.337,P<0.001), area of residence(t=2.401,P=0.019), income(t=10.462,P<0.001), and eye affected by AMD (t=3.148,P=0.003) were found statistically significant between the t-tested groups. The continuous variables anxiety (r= –0.201,P<0.05), depression(r= –0.237,P<0.01), social support (r=0.285,P<0.01), self-efficacy(r=0.300,P<0.01), VA treated eye (r=0.586,P<0.01), and BCVA (r=0.550,P<0.01) correlated significantly with the total score of NEI VFQ-25.
At the 6-month follow-up, the categorical variables gender (t=2.679,P=0.008) and income(t=3.796,P<0.001)were found statistically significant between the t-tested groups. The continuous variables anxiety (r= –0.363, P<0.01), depression(r= –0.798,P<0.01), positive coping(r=0.363, P<0.01), negative coping(r=0.328, P<0.01), social support (r=0.565, P<0.01), self-efficacy(r=0.336,P<0.01), and BCVA (r=0.412, P<0.01) correlated significantly with the total score of NEI VFQ-25.
At the 12-month follow-up, the categorical variables income (t=2.866,P=0.005) and eye affected by AMD (t=2.195,P=0.03) were found statistically significant between the t-tested groups. The continuous variables anxiety (r= –0.341,P<0.01), depression(r= –0.656,P<0.01), social support (r=0.427,P<0.01), self-efficacy (r=0.616,P<0.01), VA treated eye (r=0.193,P<0.05),and BCVA (r=0.443,P<0.01) correlated significantly with the total score of NEI VFQ-25.
The total scores of NEI VFQ-25 as the dependent variable along with statistically significant psychosocial variables and covariates were entered into the linear regression analysis (Table 4). At baseline, four covariates (BCVA, income, depression, and VA treated eye) remained significant predictors of NEI VFQ-25 total scores, and the coefficient of determination R2 was 0.559. At the 1-month follow-up, two covariates (BCVA and income) and one psychosocial variable (depression) remained significant predictors of NEI VFQ-25 total scores, and the coefficient of determination R2 was 0.403. At the 3-month follow-up, six covariates (education, area of residence, gender, VA treated eye, BCVA, and income) and four psychosocial variables (anxiety, social support, self-efficacy, and depression) remained significant predictors of NEI VFQ-25 total scores, and the coefficient of determination R2 was 0.833. At the 6-month follow-up, three covariates (gender, BCVA, and income) and six psychosocial variables (anxiety, social support, self-efficacy, depression, negative coping, and positive coping) remained significant predictors of NEI VFQ-25 total scores, and the coefficient of determination R2 was 0.748. At the 12-month follow-up, two covariates (BCVA and eye affected by AMD) and three psychosocial variables (social support, self-efficacy, and depression) remained significant predictors of NEI VFQ-25 total scores, and the coefficient of determination R2 was 0.509.
Table 2 Comparison of mean NEI VFQ-25 according to categorical variables at baseline and follow-ups
Demographic and clinical features
|
VFQ-25 score
|
Baseline
(N=142)
|
1 month follow-up
(N=137)
|
3 months follow-up
(N=131)
|
6 months follow-up
(N=128)
|
12 months follow-up
(N=115)
|
Gender
|
|
|
|
|
|
Male
|
60.00±15.09(n=69)
|
64.68±16.27*(n=67)
|
57.83±12.03**(n=63)
|
59.35±13.47**(n=62)
|
62.26±16.97(n=55)
|
Female
|
58.23±17.54(n=73)
|
58.93±15.89(n=70)
|
51.12±14.38(n=68)
|
53.51±11.16(n=66)
|
56.71±19.25(n=60)
|
Education
|
|
|
|
|
|
Primary or lower
|
55.41±18.99(n=33)
|
58.18±19.51(n=32)
|
42.83±9.01**(n=30)
|
54.23±13.46(n=29)
|
58.54±19.22(n=24)
|
Secondary
|
57.46±17.51(n=51)
|
65.35±15.07(n=47)
|
57.26±10.74(n=45)
|
57.21±13.20(n=45)
|
60.27±15.54(n=39)
|
Tertiary or higher
|
62.62±12.97(n=58)
|
60.79±14.93(n=58)
|
58.17±13.67(n=56)
|
56.74±11.76(n=54)
|
59.37±18.33(n=52)
|
Marital status
|
|
|
|
|
|
Married
|
63.12±17.23**(n=98)
|
63.37±16.44(n=96)
|
54.47±13.67(n=97)
|
57.19±12.90(n=95)
|
58.34±18.29(n=93)
|
Not currently married
|
50.11±9.4(n=44)
|
57.93±15.41(n=41)
|
53.98±13.88(n=34)
|
53.90±11.64(n=33)
|
63.71±18.28(n=22)
|
Area of residence
|
|
|
|
|
|
Urban
|
61.02±16.64**(n=114)
|
61.80±14.08(n=114)
|
55.15±14.58*(n=109)
|
57.21±12.90(n=106)
|
60.04±18.37(n=94)
|
Rural
|
51.26±12.69(n=28)
|
61.47±24.87(n=23)
|
50.36±6.67(n=22)
|
52.16±10.51(n=22)
|
56.33±18.25(n=21)
|
Income
|
|
|
|
|
|
≥10,000RMB
|
69.52±13.64**(n=62)
|
71.46±13.09**(n=57)
|
65.02±11.35**(n=56)
|
60.98±13.69**(n=55)
|
65.29±16.32**(n=45)
|
<10,000RMB
|
51.01±13.53(n=80)
|
54.82±14.76(n=80)
|
46.37±9.05(n=75)
|
52.84±10.57(n=73)
|
55.56±18.64(n=70)
|
Eye affected by AMD
|
|
|
|
|
|
Unilateral cases
|
61.23±16.05**(n=112)
|
63.97±15.52**(n=109)
|
55.63±14.30**(n=107)
|
56.83±13.14(n=106)
|
61.16±17.46*(n=93)
|
Bilateral cases
|
51.12±15.26(n=30)
|
53.10±16.55(n=28)
|
48.62±8.54(n=24)
|
53.97±9.71(n=22)
|
51.78±20.33(n=22)
|
Note: *P<0.05, **P<0.01
Table 3 Correlations between total score of the NEI VFQ-25 and continuous variables at baseline and follow-ups
Variables
|
NEI VFQ-25 score
|
Baseline
|
1 month follow-up
|
3 months follow-up
|
6 months follow-up
|
12 months follow-up
|
Age
|
0.151
|
0.147
|
-0.050
|
-0.070
|
0.062
|
VA treated eye
|
0.409**
|
0.231**
|
0.586**
|
0.063
|
0.193*
|
BCVA
|
0.608**
|
0.419**
|
0.550**
|
0.412**
|
0.443**
|
No. of intravitreal injections
|
|
-0.045
|
-0.125
|
0.115
|
0.136
|
Anxiety
|
-0.130
|
- 0.537**
|
- 0.201*
|
- 0.363**
|
- 0.341**
|
Depression
|
-0.270**
|
- 0.533**
|
- 0.237**
|
- 0.798**
|
- 0.656**
|
Positive Coping
|
0.053
|
0.068
|
0.140
|
0.363**
|
0.048
|
Negative Coping
|
-0.259**
|
- 0.075
|
- 0.001
|
- 0.328**
|
-0.081
|
Social Support
|
0.007
|
0.165
|
0.285**
|
0.565**
|
0.427**
|
Self-efficacy
|
0.051
|
0.272**
|
0.300**
|
0.336**
|
0.616**
|
Note: *P<0.05, **P<0.01
Table 4. Linear regression analysis of predictors of quality of life at baseline and follow-ups
Variables
|
UnstandardizedCoefficients Beta
|
Std. Error
|
Standardized
Coefficients Beta
|
t
|
P value
|
95% Confidence interval for B
|
Lower Bound
|
Upper Bound
|
Baseline
|
|
(Constant)
|
79.843
|
6.135
|
|
13.015
|
.000
|
67.712
|
91.975
|
BCVA
|
24.499
|
3.494
|
.458
|
7.012
|
.000
|
17.589
|
31.408
|
Income
|
-8.652
|
2.204
|
-.263
|
-3.926
|
.000
|
-13.010
|
-4.294
|
Depression
|
-7.454
|
2.304
|
-.182
|
-3.235
|
.002
|
-12.010
|
-2.898
|
VA treated eye
|
4.290
|
2.119
|
.122
|
2.025
|
.045
|
8.480
|
101.000
|
1 Month follow-up
|
|
(Constant)
|
84.703
|
6.122
|
|
13.836
|
.000
|
72.590
|
96.815
|
BCVA
|
11.851
|
3.651
|
.237
|
3.246
|
.001
|
4.627
|
19.075
|
Income
|
-7.287
|
2.387
|
-.228
|
-3.052
|
.003
|
-12.011
|
-2.563
|
Depression
|
-.529
|
.235
|
-.231
|
-2.247
|
.026
|
-.994
|
-.063
|
3 Months follow-up
|
|
(Constant)
|
60.453
|
6.748
|
|
8.958
|
.000
|
47.092
|
73.815
|
Anxiety
|
-.732
|
.100
|
-.495
|
-7.288
|
.000
|
-.931
|
-.533
|
VA treated eye
|
34.764
|
5.160
|
.551
|
6.738
|
.000
|
24.549
|
44.980
|
Social Support
|
.278
|
.053
|
.272
|
5.216
|
.000
|
.384
|
.173
|
Self-Efficacy
|
.684
|
.136
|
.316
|
5.034
|
.000
|
.415
|
.953
|
Income
|
-6.337
|
1.399
|
-.230
|
-4.530
|
.000
|
-9.106
|
-3.567
|
Education
|
3.158
|
.702
|
.182
|
4.497
|
.000
|
1.767
|
4.548
|
Depression
|
-.637
|
.188
|
-.279
|
-3.383
|
.001
|
-.264
|
-1.010
|
BCVA
|
11.508
|
3.811
|
.231
|
3.020
|
.003
|
19.053
|
3.963
|
Area of residence
|
-4.835
|
1.906
|
-.133
|
-2.537
|
.012
|
-1.061
|
-8.609
|
Gender
|
-2.786
|
1.151
|
-.102
|
-2.422
|
.017
|
-5.064
|
-.508
|
6 Months follow-up
|
|
(Constant)
|
105.511
|
11.282
|
|
9.352
|
.000
|
83.169
|
127.854
|
Depression
|
-1.974
|
.179
|
-1.690
|
-11.025
|
.000
|
-2.329
|
-1.620
|
Anxiety
|
1.902
|
.275
|
.945
|
6.910
|
.000
|
1.357
|
2.447
|
Negative coping
|
-1.397
|
.270
|
-.325
|
-5.175
|
.000
|
-1.931
|
-.862
|
Social Support
|
.430
|
.096
|
.275
|
4.467
|
.000
|
.240
|
.621
|
Positive coping
|
.823
|
.189
|
.243
|
4.350
|
.000
|
.448
|
1.198
|
Gender
|
-6.563
|
1.553
|
-.261
|
-4.227
|
.000
|
-9.638
|
-3.488
|
Self-Efficacy
|
-.606
|
.141
|
-.264
|
4.307
|
.000
|
-.885
|
-.328
|
BCVA
|
14.622
|
3.728
|
.247
|
3.922
|
.000
|
22.004
|
7.240
|
Income
|
-3.466
|
1.439
|
-.136
|
-2.408
|
.018
|
-6.316
|
-.615
|
12 Months follow-up
|
|
(Constant)
|
26.270
|
10.321
|
|
2.545
|
.012
|
5.814
|
46.726
|
Self–Efficacy
|
1.082
|
.187
|
.424
|
5.785
|
.000
|
.711
|
1.452
|
BCVA
|
19.478
|
4.658
|
.285
|
4.181
|
.000
|
10.245
|
28.710
|
Depression
|
-.316
|
.114
|
-.196
|
-2.759
|
.007
|
-.542
|
-.089
|
Eye affected by AMD
|
-8.737
|
3.216
|
-.188
|
-2.717
|
.008
|
-15.112
|
-2.363
|
Social Support
|
.215
|
.093
|
.173
|
2.302
|
.023
|
.030
|
.400
|