Table 3.
Implant (events=77; n=196 eyes; 3,201 complete case 3-mo eye-visits) | Systemic (events=16; n=209 eyes; 4,024 complete case 3-mo eye-visits) | ||||||
---|---|---|---|---|---|---|---|
IOP Definition‡ | IOP category -mmHg | Rate /100 Eye-Years | Events/3-mo eye-visit | P-value* vs. Reference (Ref) group | Rate /100 Eye-Years | Events/ 3-mo eye-visit | P-value* vs. Ref group |
Baseline | <16 | 8.4 | 40/1901 | Ref | 1.2 | 8/2642 | Ref |
16–20 | 11.2 | 34/1214 | 0.18 | 2.8 | 8/1351 | 0.09 | |
21–24 | 14.0 | 3/86 | 0.33 | 0.0 | 0/242 | -- | |
25–29 | -- | 0/0 | -- | 0.0 | 0/9 | -- | |
30–39 | -- | 0/0 | -- | -- | 0/0 | -- | |
40–49 | -- | 0/0 | -- | -- | 0/0 | -- | |
50+ | -- | 0/0 | -- | -- | 0/0 | -- | |
HR (95% CI) /cat† | 1.3 (0.9, 1.9) | 0.12 | 1.3 (0.7, 2.4) | 0.42 | |||
Time-updated | <16 | 8.8 | 37/1654 | Ref | 0.6 | 4/2748 | Ref |
16–20 | 8.2 | 19/925 | 0.96 | 3.2 | 8/1008 | 0.004 | |
21–24 | 13.5 | 9/266 | 0.05 | 4.8 | 2/163 | 0.003 | |
25–29 | 4.6 | 2/173 | 0.71 | 6.4 | 1/62 | 0.001 | |
30–39 | 11.4 | 4/140 | 0.18 | 12.5 | 1/32 | <0.001 | |
40–49 | 51.3 | 5/39 | 0.001 | 0.0 | 0/8 | -- | |
50+ | 44.4 | 1/9 | <0.001 | 0.0 | 0/1 | -- | |
HR (95% CI) /cat† | 1.3 (1.1, 1.5) | 0.001 | 2.3 (1.7, 3.1) | <0.001 | |||
Time-updated Cumulative Average | <16 | 3.6 | 10/1153 | Ref | 0.8 | 5/2551 | Ref |
16–20 | 10.0 | 37/1455 | 0.02 | 2.8 | 9/1344 | 0.05 | |
21–24 | 20.0 | 23/460 | <0.001 | 7.2 | 2/107 | 0.001 | |
25–29 | 16.4 | 5/122 | <0.001 | 0.0 | 0/18 | -- | |
30–39 | 53.2 | 2/15 | <0.001 | 0.0 | 0/4 | -- | |
40–49 | 0.0 | 0/7 | -- | -- | -- | -- | |
50+ | -- | -- | -- | -- | -- | ||
HR (95% CI) / cat† | 2.0 (1.6, 2.5) | <0.001 | 2.8 (1.5, 5.1) | 0.001 | |||
Time-updated Maximum | <16 | 0.0 | 0/508 | NC | 0.0 | 0/987 | NC |
16–20 | 3.0 | 5/667 | Ref | 0.8 | 4/1824 | Ref | |
21–24 | 3.6 | 5/538 | 0.98 | 2.4 | 4/704 | 0.32 | |
25–29 | 7.2 | 9/499 | 0.36 | 6.0 | 4/270 | 0.03 | |
30–39 | 24.8 | 40/687 | <0.001 | 8.8 | 4/182 | 0.007 | |
40–49 | 20.3 | 13256 | 0.005 | 0.0 | 0/52 | NC | |
50+ | 35.1 | 5/57 | 0.002 | 0.0 | 0/5 | NC | |
HR (95% CI) /cat† | 1.6 (1.4, 1.9) | <0.001 | 1.7 (1.3, 2.3) | <0.001 |
Note: Eyes with IOP>24 mmHg at baseline were not eligible for enrollment into the study. Mo=month. HR=hazard ratio; CI=confidence interval. Cat=category. Ref=reference group. Event=diagnosis with glaucoma.
Derived from Cox regression accounting for between-eye correlation
P-value for interaction of treatment group and IOP category = 0.86 for Baseline IOP; 0.002 for Time-updated IOP; 0.52 for Time-updated Average IOP; and 0.71 for Time-updated Max IOP
IOP was defined 4 ways: 1) Baseline IOP using the IOP at the baseline visit; 2) time-updated IOP using the IOP at that visit; 3) time-updated average IOP using the average IOP up through that visit; and 4) time-updated max IOP using the highest IOP up through that visit.