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. Author manuscript; available in PMC: 2018 Jul 13.
Published in final edited form as: JAMA Ophthalmol. 2016 Dec 1;134(12):1365–1372. doi: 10.1001/jamaophthalmol.2016.4096

Table 3.

Prespecified Primary and Secondary Outcomes

Modela Result (95% CI)b P Value
Primaryanalysis: Coxproportional hazards regression indicating hazard of perforation or need for TPK (n = 237)
 Voriconazole vs placebo 0.82 (0.57 to 1.18) .29
 Enrollment infiltrate and/or scar 1.29 (1.15 to 1.45) <.001
Primary analysis: interaction between treatment and organism subgroup (n = 234)
Fusarium species: voriconazole vs placebo 0.49 (0.26 to 0.92) .03
Aspergillus species: voriconazole vs placebo 0.78 (0.38 to 1.61) .50
 Other species: voriconazole vs placebo 1.23 (0.69 to 2.19) .47
 Interaction between organism subgroup and treatment .15c
Mixed linear regression indicating 3-mo BSCVA (n = 181)d
 Voriconazole vs placebo −0.02 (−0.18 to 0.14) .77
Mixed linear regression indicating 3-mo infiltrate or scar (n = 195)d
 Voriconazole vs placebo −0.16 (−0.49 to 0.17) .35
Cox proportional hazards regression indicating time to re-epithelialization (n = 238)d
 Voriconazole vs placebo 0.87 (0.49 to 1.57) .65

Abbreviations: BSCVA, best spectacle-corrected visual acuity; TPK, therapeutic penetrating keratoplasty.

a

All models corrected for site using random effects.

b

Cox proportional hazards regression yields a hazard ratio and the mixed linear regressions yield an effect coefficient.

c

Wald test for interaction.

d

Controlled for baseline values.