Table 3.
Change in National Eye Institute Visual Function Questionnaire (NEI-VFQ) Scores from Baseline to Follow-up Visits*
|
6 Months |
12 Months |
24 Months |
36 Months |
48 Months |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Obs (n = 204) | Sur (n = 215) | Obs (n = 199) | Sur (n = 207) | Obs (n = 186) | Sur (n = 198) | Obs (n = 143) | Sur (n = 145) | Obs (n = 82) | Sur (n = 84) | |
| Interview completion | ||||||||||
| Expected (n) | 222 | 225 | 221 | 221 | 213 | 215 | 179 | 166 | 100 | 96 |
| % interviewed | 92 | 96 | 90 | 94 | 87 | 92 | 80 | 87 | 82 | 88 |
| Overall NEI-VFQ [n (%)] | ||||||||||
| ≥17 | 11 (5) | 16 (7) | 10 (5) | 21 (10) | 14 (8) | 21 (11) | 12 (8) | 10 (7) | 9 (11) | 13 (15) |
| 6–16 | 45 (22) | 57 (27) | 46 (23) | 48 (23) | 34 (18) | 49 (25) | 20 (14) | 36 (25) | 16 (20) | 24 (29) |
| −5 to 5 | 81 (40) | 93 (43) | 69 (35) | 83 (40) | 57 (31) | 68 (34) | 43 (30) | 47 (32) | 27 (33) | 19 (23) |
| −6 to −16 | 47 (23) | 39 (18) | 50 (25) | 34 (16) | 46 (25) | 35 (18) | 39 (27) | 26 (18) | 8 (10) | 11 (13) |
| ≤−17 | 20 (10) | 10 (5) | 24 (12) | 21 (10) | 35 (19) | 25 (13) | 29 (20) | 26 (18) | 22 (27) | 17 (20) |
| Median | −1 | 1 | −1 | 1 | −3 | 1 | −5 | −2 | 0 | 2 |
| 95% CI | −2 to 2 | −1 to 3 | −3 to 0 | 0–3 | −6 to −2 | −1 to 3 | −7 to −2 | −4 to 2 | −4 to 2 | −3 to 8 |
| Wilcoxon P value† | — | — | 0.003 | — | — | |||||
| General vision [n (%)] | ||||||||||
| ≥17 | 27 (13) | 34 (16) | 21 (11) | 37 (18) | 20 (11) | 33 (17) | 13 (9) | 18 (12) | 7 (9) | 14 (17) |
| 6–16 | 33 (16) | 45 (21) | 35 (18) | 37 (18) | 30 (16) | 36 (18) | 22 (15) | 25 (17) | 8 (10) | 16 (19) |
| −5 to 5 | 84 (41) | 79 (37) | 84 (42) | 79 (38) | 77 (41) | 71 (36) | 52 (36) | 52 (36) | 31 (38) | 23 (27) |
| −6 to −16 | 30 (15) | 35 (16) | 26 (13) | 32 (15) | 19 (10) | 29 (15) | 21 (15) | 28 (19) | 14 (17) | 17 (20) |
| ≤−17 | 30 (15) | 22 (10) | 33 (17) | 22 (11) | 40 (22) | 29 (15) | 35 (24) | 22 (15) | 22 (27) | 13 (15) |
| Median | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | −5 | 0 |
| 95% CI | 0–5 | 0–5 | −5 to 0 | 0–5 | −5 to 0 | 0–5 | −5 to 0 | −5 to 5 | −10 to 0 | −5 to 5 |
| Wilcoxon P value† | — | — | 0.10 | — | — | |||||
| Driving, no. (%) | ||||||||||
| ≥17 | 17 (8) | 32 (15) | 26 (13) | 26 (13) | 16 (9) | 20 (10) | 11 (8) | 10 (7) | 9 (11) | 4 (5) |
| 6–16 | 27 (13) | 14 (7) | 13 (7) | 18 (9) | 13 (7) | 17 (9) | 6 (4) | 5 (3) | 1 (1) | 3 (4) |
| −5 to 5 | 75 (37) | 90 (42) | 67 (34) | 77 (37) | 65 (35) | 74 (37) | 51 (36) | 53 (37) | 28 (34) | 30 (36) |
| −6 to −16 | 15 (7) | 13 (6) | 18 (9) | 13 (6) | 10 (5) | 10 (5) | 5 (4) | 9 (6) | 1 (1) | 5 (6) |
| ≤−17 | 36 (18) | 38 (18) | 38 (19) | 48 (23) | 57 (31) | 50 (25) | 51 (36) | 47 (32) | 27 (33) | 27 (32) |
| Median | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 95% CI | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | −8 to 0 | −8 to 0 | −33 to 0 | −17 to 0 |
| Wilcoxon P value† | — | — | 0.22 | — | — | |||||
| Near activities [n (%)] | ||||||||||
| ≥17 | 20 (10) | 46 (21) | 27 (14) | 41 (20) | 32 (17) | 42 (21) | 30 (21) | 31 (21) | 18 (22) | 18 (21) |
| 6–16 | 47 (23) | 33 (15) | 35 (18) | 38 (18) | 26 (14) | 29 (15) | 15 (10) | 20 (14) | 15 (18) | 11 (13) |
| −5 to 5 | 64 (31) | 74 (34) | 58 (29) | 68 (33) | 47 (25) | 59 (30) | 31 (22) | 33 (23) | 20 (24) | 27 (32) |
| −6 to −16 | 40 (20) | 33 (15) | 23 (12) | 30 (14) | 30 (16) | 26 (13) | 25 (17) | 24 (17) | 5 (6) | 6 (7) |
| ≤−17 | 33 (16) | 29 (13) | 56 (28) | 30 (14) | 50 (27) | 42 (21) | 42 (29) | 37 (26) | 24 (29) | 22 (26) |
| Median | 0 | 0 | 0 | 0 | −4 | 0 | −4 | −4 | 4 | 0 |
| 95% CI | −4 to 0 | 0–4 | −4 to 4 | 0–4 | −8 to 0 | −4 to 0 | −8 to 0 | −4 to 0 | −4 to 8 | −4 to 4 |
| Wilcoxon P value† | — | — | 0.14 | — | — | |||||
| Distance activities [n (%)] | ||||||||||
| ≥17 | 26 (13) | 44 (20) | 25 (13) | 36 (17) | 32 (17) | 42 (21) | 25 (17) | 22 (15) | 16 (20) | 24 (29) |
| 6–16 | 31 (15) | 38 (18) | 33 (17) | 39 (19) | 22 (12) | 32 (16) | 10 (7) | 22 (15) | 14 (17) | 11 (13) |
| −5 to 5 | 71 (35) | 70 (33) | 58 (29) | 61 (29) | 46 (25) | 52 (26) | 43 (30) | 38 (26) | 15 (18) | 21 (25) |
| −6 to −16 | 38 (19) | 30 (14) | 33 (17) | 32 (15) | 34 (18) | 29 (15) | 23 (16) | 23 (16) | 12 (15) | 3 (4) |
| ≤−17 | 38 (19) | 33 (15) | 50 (25) | 39 (19) | 52 (28) | 43 (22) | 42 (29) | 40 (28) | 25 (30) | 25 (30) |
| Median | −1 | 0 | −4 | 0 | −4 | 0 | −4 | 0 | −4 | 0 |
| 95% CI | −4 to 0 | 0–4 | −4 to 0 | −4 to 4 | −8 to 0 | −4 to 4 | −8 to 0 | −7 to 0 | −8 to 4 | −4 to 7 |
| Wilcoxon P value† | — | — | 0.08 | — | — | |||||
| Role difficulties [n (%)] | ||||||||||
| ≥+17 | 29 (14) | 39 (18) | 26 (13) | 37 (18) | 24 (13) | 42 (21) | 17 (12) | 27 (19) | 11 (13) | 22 (26) |
| 6–16 | 49 (24) | 54 (25) | 46 (23) | 46 (22) | 38 (20) | 39 (20) | 33 (23) | 22 (15) | 15 (18) | 16 (19) |
| −5 to 5 | 30 (15) | 37 (17) | 27 (14) | 39 (19) | 21 (11) | 25 (13) | 14 (10) | 24 (17) | 7 (9) | 8 (10) |
| −6 to −16 | 45 (22) | 40 (19) | 47 (24) | 50 (24) | 38 (20) | 45 (23) | 27 (19) | 31 (21) | 16 (20) | 15 (18) |
| ≤−17 | 51 (25) | 45 (21) | 53 (27) | 35 (17) | 64 (34) | 47 (24) | 52 (36) | 41 (28) | 33 (40) | 23 (27) |
| Median | 0 | 0 | −6 | 0 | −6 | 0 | −6 | 0 | −9 | 0 |
| 95% CI | −6 to 0 | 0–6 | −6 to 0 | 0–0 | −12 to 0 | −6 to 0 | −12 to 0 | −6 to 0 | −19 to 0 | −6 to 6 |
| Wilcoxon P value† | — | — | 0.03 | — | — | |||||
| Mental health [n (%)] | ||||||||||
| ≥17 | 32 (16) | 44 (20) | 32 (16) | 51 (25) | 29 (16) | 56 (28) | 27 (19) | 35 (24) | 18 (22) | 28 (33) |
| 6–16 | 34 (17) | 46 (21) | 31 (16) | 35 (17) | 33 (18) | 32 (16) | 19 (13) | 24 (17) | 15 (18) | 16 (19) |
| −5 to 5 | 71 (35) | 61 (28) | 67 (34) | 72 (35) | 52 (28) | 58 (29) | 46 (32) | 36 (25) | 25 (30) | 17 (20) |
| −6 to −16 | 30 (15) | 32 (15) | 27 (14) | 21 (10) | 23 (12) | 23 (12) | 21 (15) | 19 (13) | 6 (7) | 9 (11) |
| ≤−17 | 37 (18) | 32 (15) | 42 (21) | 28 (14) | 48 (26) | 29 (15) | 30 (21) | 31 (21) | 18 (22) | 14 (17) |
| Median | 0 | 5 | 0 | 5 | −5 | 5 | 0 | 0 | 2 | 10 |
| 95% CI | −5 to 5 | 0–5 | −5 to 5 | 0–5 | −5 to 0 | 0–10 | −5 to 5 | −5 to 5 | −5 to 10 | 0–15 |
| Wilcoxon P value† | — | — | 0.0007 | — | — | |||||
| Dependency [n (%)] | ||||||||||
| ≥17 | 38 (19) | 46 (21) | 41 (21) | 49 (24) | 33 (18) | 48 (24) | 22 (15) | 31 (21) | 17 (21) | 19 (23) |
| 6–16 | 34 (17) | 36 (17) | 35 (18) | 40 (19) | 33 (18) | 24 (12) | 20 (14) | 33 (23) | 13 (16) | 17 (20) |
| −5 to 5 | 48 (24) | 59 (27) | 39 (20) | 53 (26) | 25 (13) | 50 (25) | 24 (17) | 25 (17) | 11 (13) | 12 (14) |
| −6 to −16 | 31 (15) | 34 (16) | 31 (16) | 28 (14) | 33 (18) | 29 (15) | 20 (14) | 19 (13) | 8 (10) | 14 (17) |
| ≤−17 | 53 (26) | 40 (19) | 53 (27) | 37 (18) | 61 (33) | 47 (24) | 57 (40) | 37 (26) | 33 (40) | 22 (26) |
| Median | 0 | 0 | 0 | 0 | −6 | 0 | −6 | 0 | −3 | 0 |
| 95% CI | 0–0 | 0–0 | 0–0 | 0–6 | −6 to 0 | 0–0 | −12 to 0 | 0–6 | −19 to 6 | −6 to 6 |
| Wilcoxon P value† | — | — | 0.03 | — | — | |||||
| Social functioning [n (%)] | ||||||||||
| ≥17 | 34 (17) | 47 (22) | 43 (22) | 51 (25) | 44 (24) | 48 (24) | 30 (21) | 31 (21) | 21 (26) | 26 (31) |
| 6–16 | 31 (15) | 37 (17) | 27 (14) | 30 (14) | 22 (12) | 28 (14) | 26 (18) | 23 (16) | 14 (17) | 10 (12) |
| −5 to 5 | 60 (29) | 63 (29) | 60 (30) | 65 (31) | 51 (27) | 54 (27) | 28 (20) | 32 (22) | 16 (20) | 12 (14) |
| −6 to −16 | 22 (11) | 35 (16) | 26 (13) | 21 (10) | 21 (11) | 26 (13) | 22 (15) | 19 (13) | 10 (12) | 13 (15) |
| ≤−17 | 56 (27) | 33 (15) | 42 (21) | 40 (19) | 48 (26) | 41 (21) | 36 (25) | 40 (28) | 20 (24) | 23 (27) |
| Median | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 95% CI | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–8 | −8 to 8 |
| Wilcoxon P value† | — | — | 0.24 | — | — | |||||
| Peripheral vision‡ [n (%)] | ||||||||||
| ≥+25 | 57 (28) | 73 (34) | 49 (25) | 53 (26) | 58 (31) | 60 (30) | 37 (26) | 46 (32) | 31 (38) | 38 (45) |
| 0 | 83 (41) | 89 (41) | 88 (44) | 98 (47) | 74 (40) | 77 (39) | 56 (39) | 56 (39) | 33 (40) | 29 (35) |
| ≤−25 | 62 (30) | 52 (24) | 61 (31) | 55 (27) | 53 (28) | 57 (29) | 48 (34) | 39 (27) | 18 (22) | 16 (19) |
| Median | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 95% CI | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–25 |
| Wilcoxon P value† | — | — | 0.82 | — | — | |||||
| Ocular pain§ [n (%)] | ||||||||||
| ≥+25 | 23 (11) | 31 (14) | 35 (18) | 34 (16) | 35 (19) | 35 (18) | 32 (22) | 24 (17) | 13 (16) | 19 (23) |
| 12 | 38 (19) | 38 (18) | 26 (13) | 34 (16) | 29 (16) | 34 (17) | 16 (11) | 23 (16) | 8 (10) | 19 (23) |
| 0 | 88 (43) | 104 (48) | 80 (40) | 95 (46) | 73 (39) | 79 (40) | 58 (41) | 70 (48) | 45 (55) | 28 (33) |
| −12 | 30 (15) | 20 (9) | 23 (12) | 26 (13) | 26 (14) | 33 (17) | 21 (15) | 18 (12) | 5 (6) | 11 (13) |
| ≤−25 | 25 (12) | 22 (10) | 35 (18) | 18 (9) | 23 (12) | 17 (9) | 16 (11) | 10 (7) | 11 (13) | 7 (8) |
| Median | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 95% CI | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–0 | 0–12 |
| Wilcoxon P value† | — | — | 0.82 | — | — | |||||
CI = confidence interval; Obs = Observation; Sur = Surgery.
*
Counts may not add up to the total number of interviews, and percentages may not add up to 100 owing to missing responses.
†
Reported for treatment arm comparison of change in NEI-VFQ scores from baseline to 24 mos only.
‡
Subscale is a 1-item scale; possible values for the scales are 0, 25, 50, 75, and 100.
§
Subscale is a 2-item scale; possible values are 0, 12.5, 25, 37.5, etc., up to 100.