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L.B. Szczotka–Flynn, S. Debanne, V. Cheruvu, B. Long, S. Dillehay, J. Barr, P. Bergenske, P. Donshik, G. Secor, J. Yoakum; Predictive Factors for Corneal Infiltrates With Lotrafilcon A Silicone Hydrogel Lenses Worn for Up to 30 Nights Continuous Wear . Invest. Ophthalmol. Vis. Sci. 2006;47(13):88.
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The probability of developing any corneal infiltrate (grades 1–4) through 3 years of continuous wear (CW) with lotrafilcon A lenses as a function of potential risk factors was modeled using survival analysis methods.
317 patients were enrolled in a non–randomized, prospective, open–label, observational study, across 19 sites in the US. All patients were bilaterally fit with lotrafilcon A lenses for up to 30 nights CW and followed for 3 years. Biomicroscopy signs were graded at each visit on the 4–point Efron Grading Scale. The outcome variable was the first occurence of any infiltrative event in either eye. Estimates of unadjusted incidence were obtained using the Kaplan–Meier method. Cox proportional hazards regression was used to model the probability of developing infiltrates as a function of demographic and biomicroscopy findings. The proportional hazards assumption was tested by introducing time–dependent covariates.
The actual occurrences of corneal infiltrates were 16 within the first year, 7 in the second year, and 4 in the third year. The Kaplan–Meier unadjusted cumulative incidence of a corneal infiltrate after continuous wear at the end of 1 year was 5.7% (3.0%, 8.4%), at the end of 2 years was 8.5% (5.2% 11.9%) and at the end of 3 years was 10.3% (6.6%, 13.9%). In a multivariate model, corneal staining and limbal redness present in the eye with an infiltrate on a previous visit were significantly associated with elevated hazard ratios for developing an infiltrative event (7.23 p <0.0001; and 3.18 p=0.018, respectively).
Limbal redness and corneal staining may predict the subsequent development of an infiltrative event among 30 night CW patients. The probability of remaining free of any corneal infiltrates for up to 1 year of CW with lotrafilcon A lenses was 94.3% (91.6%, 97.0%), at the end of 2 years was 91.5% (88.1% 94.8%) and at the end of 3 years was 89.7% (86.1%, 93.4%).
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