Table 5: Non-inferiority testing of postoperative complications without clinical marginals but including statistical marginals to allow for sampling variation. The upper limits of the two-sided 90% confidence intervals coincide with the upper limits of one-sided 95% confidence intervals for the risk difference study group vs. control. P-values below 0.05 establish non-inferiority of the study group.

Postoperative complication

Reference incidence (%)

Reference implied marginal (%)

Upper 90% (%)

p-valuea)

0-3 months postoperatively

 

 

 

 

Postoperative CME

1.17

0.36

0.33

0.03*

Persistent anterior uveitis

1.75

0.44

0.18

0.01*

Retinal Detachment

0.25

0.17

0.11

0.01*

Corneal decompensation

1.00

0.33

0.05

< 0.001*

Dry AMD progression to exudative AMD

0.60

0.26

0.11

0.002*

Malignant glaucoma

0.60

 

 

 

0-12 months postoperatively

 

 

 

 

Postoperative CME

1.17

0.37

0.40

0.08

Persistent anterior uveitis

1.75

0.45

0.24

0.001*

Retinal Detachment

0.43

0.22

0.17

0.01*

Corneal decompensation

1.00

0.34

0.04

< 0.001*

Dry AMD progression to exudative AMD

2.40

0.52

0.48

0.03*

Malignant glaucoma

0.06

 

 

 

a) Farrington-Manning method, AMD: Age Related Macular Degeneration; CME: Cystic Macular Edema, *= statistically significant