Abstract
Abstract: :
Purpose: Determine effects of daily (DW) and 6 and 30 night (N) EW of a novel hyper-O2 transmissible CTL vs conventional materials in a prospective randomized, double-masked, single center clinical trial (1 year). Methods: Test lenses: Ciba "Night & Day" (n = 98), Vistakon "Acuvue" (n = 70). Main outcome measures: Pseudomonas aeruginosa (PA) binding to exfoliated corneal surface cells; central corneal epithelial thickness (ET), surface cell size (SIZE) and desquamation rate (DESQ), measured at: baseline, 2 and 4 weeks DW, and 1, 3, 6, 9, and 12 months EW; 1 or 2 way ANOVA analysis. Results: DW: PA binding was significantly less with wear of the hyper-O2 lens vs conventional lens (p<0.01); no significant differences between lenses with ET, SIZE and DESQ. EW: PA binding significantly less with wear of hyper-O2 material; (p<0.01), (no difference 6 vs 30N wear); adaptation (less PA binding) with return to baseline levels at 6M EW seen with both test lenses; significant increases in SIZE, decreases in ET and DESQ persisted with both test lenses but significantly less in hyper-O2 lens wear. Conclusions: (1) Consistent with results seen in clinical trials with two other hyper-O2 lenses (Ophthalmology 2001;108:1279-88 and 2002;109:27-39), these results suggest that use of these novel hyper-O2 materials in DW or EW should decrease the incidence of and prospective risks for CTL-associated infectious keratitis; (2) all EW produce stagnation of the ocular surface, (increased SIZE; decreased DESQ; decreased ET) but significantly less with hyper-O2 soft materials wear.
Keywords: 367 contact lens • 369 cornea: clinical science • 531 Pseudomonas