Table 4.
Sensitivity analyses of factors influencing the initial and trajectory of VFQ-25 composite scores during the first 3 years of follow-up for individuals assigned to receive systemic therapy in the MUST Trial and Follow-up Study. Worse eye analyses were based upon the visual acuity in the worse seeing eye and the visual field in the same eye only (Version I) or used the visual field for the other eye if not available (Version II). Better eye analyses were based upon the visual acuity in better eye and the corresponding visual field measurements. The Per Protocol analysis only included individuals who received systemic therapy within 6 months of randomization and censored follow-up at the time of first implantation. The visual acuity threshold was 20/40 for all analyses except for the one labeled 20/50.
| Characteristic | Worse Eye Analyses | Better Eye Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Version I (N = 117) |
Version II (N = 125) |
Per Protocol (N = 119) |
20/50 (N = 125) |
|||||||||
| VFQ at Baseline: N (%) Estimate (95% CI) P-value* | ||||||||||||
|
| ||||||||||||
| Worse visual acuity | 71 (61%) | −5.90 (−12.39, 0.60) | 0.075 | 79 (63%) | −6.71 (−13.21, −0.21) | 0.043 | 33 (28%) | −16.39 (−24.17, −8.61) | < 0.001 | 24 (19%) | −16.00 (−24.27, −7.72) | < 0.001 |
| Moderate Visual Field Impairment (−3db to −6db) | 41 (35%) | −7.89 (−15.22, −0.56) | 0.035 | 42 (34%) | −9.31 (−16.35, −2.27) | 0.009 | 33 (28%) | −8.97 (−15.85, −2.10) | 0.010 | 33 (26%) | −9.87 (−16.63, −3.10) | 0.004 |
| Severe Visual Field Impairment (<−6db) | 52 (44%) | −10.92 (−18.13, −3.72) | 0.003 | 58 (46%) | −12.69 (−19.74, −5.63) | < 0.001 | 34 (29%) | −12.67 (−20.48, −4.85) | 0.001 | 37 (30%) | −13.14 (−20.54, −5.73) | < 0.001 |
| Male | 24 (21%) | 4.40 (−2.28, 11.07) | 0.20 | 26 (21%) | 2.88 (−4.35, 10.12) | 0.43 | 23 (19%) | 0.27 (−6.39, 6.93) | 0.94 | 26 (21%) | 1.54 (−4.97, 8.04) | 0.64 |
| African American | 27 (23%) | 0.43 (−7.77, 8.64) | 0.92 | 31 (25%) | 1.59 (−6.07, 9.24) | 0.68 | 31 (26%) | 2.67 (−4.57, 9.91) | 0.47 | 31 (25%) | 2.57 (−4.55, 9.70) | 0.48 |
| For each 10 years older than 45 at RZ | 117 (100%) | −0.85 (−2.90, 1.20) | 0.41 | 125 (100%) | −0.77 (−2.75, 1.21) | 0.44 | 119 (100%) | −0.02 (−1.82, 1.79) | 0.98 | 125 (100%) | −0.26 (−2.02, 1.50) | 0.77 |
| Posterior/panuveitis | 74 (63%) | 2.96 (−3.36, 9.28) | 0.36 | 78 (62%) | 0.10 (−5.93, 6.12) | 0.97 | 73 (61%) | −1.13 (−7.19, 4.93) | 0.72 | 78 (62%) | −1.58 (−7.46, 4.30) | 0.60 |
|
| ||||||||||||
| Change in VFQ from Randomization to Follow-up: N (%) Estimate (95% CI) P-value* | ||||||||||||
|
| ||||||||||||
| For every additional 6 months from randomization | 616 (100%) | 1.62 (1.07, 2.17) | < 0.001 | 660 (100%) | 1.57 (1.04, 2.11) | < 0.001 | 583 (100%) | 1.49 (0.89, 2.08) | < 0.001 | 660 (100%) | 1.57 (1.04, 2.11) | < 0.001 |
Adjusted for all factors simultaneously.
RZ = randomization; FU = follow-up; CI = confidence interval.