Dataset Information

Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses.

ABSTRACT: This study determined which microbiologic, clinical, demographic, and behavioral factors are associated with corneal infiltrative events (CIEs) during continuous wear of silicone hydrogel (SH) contact lenses.Subjects (n = 205) were fitted with lotrafilcon A lenses for continuous wear and observed for 1 year. The main exposures of interest were corneal staining and bacterial lens contamination. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining CIE free, and Cox proportional hazards regression was used to model the hazard of having a CIE, as a function of key predictor variables.The KM-unadjusted cumulative probability of remaining CIE free was 73.3%. Approximately 53% of subjects had repeated episodes of corneal staining (mild or greater), and 11.3% had repeated episodes of moderate or greater corneal staining. Corneal staining was not associated with the development of a CIE. The frequency of substantial bacterial bioburden on worn lenses at the time of a CIE was 64.7%, compared with only 12.2% during uncomplicated wear. The presence of substantial lens bacterial bioburden was associated with the development of a CIE (adjusted hazards ratio [HR], 8.66; 95% confidence interval [CI], 2.88-26.01). Smoking was also associated with a CIE (adjusted HR, 4.13; 95% CI, 1.27-13.45).Corneal staining is common during continuous wear of SH lenses, but it is not associated with the development of a CIE. Smoking and substantial lens bacterial bioburden pose prominent risks of a CIE. In this study, more than 70% of the total risk of CIE in those with substantial lens bioburden is attributable to this exposure. (ClinicalTrials.gov number, NCT00727402).

SUBMITTER: Szczotka-Flynn L

PROVIDER: S-EPMC3061493 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses.

Szczotka-Flynn Loretta L Lass Jonathan H JH Sethi Ajay A Debanne Sara S Benetz Beth Ann BA Albright Matthew M Gillespie Beth B Kuo Jana J Jacobs Michael R MR Rimm Alfred A

Investigative ophthalmology & visual science 20100610 11

<h4>Purpose</h4>This study determined which microbiologic, clinical, demographic, and behavioral factors are associated with corneal infiltrative events (CIEs) during continuous wear of silicone hydrogel (SH) contact lenses.<h4>Methods</h4>Subjects (n = 205) were fitted with lotrafilcon A lenses for continuous wear and observed for 1 year. The main exposures of interest were corneal staining and bacterial lens contamination. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted ...[more]

PMID: 20538985

Similar Datasets

Project description:PurposeMicrobial contamination of contact lenses is associated with corneal infection and inflammation. This study determined the microbiological, clinical, and demographic factors that are associated with bacterial contamination of a silicone hydrogel contact lens when worn for continuous wear (CW).MethodsTwo hundred five healthy subjects were enrolled in the Longitudinal Analysis of Silicone Hydrogel Contact Lens Study and were fitted with lotrafilcon A lenses for monthly CW and followed for 1 year. Lenses were aseptically removed after 1 week and 4 months of wear and cultured using an agar sandwich technique. Lids and conjunctiva were routinely cultured at baseline and after 1 week and 4 months of CW. Lenses and ocular sites were considered to have substantial microbial bioburden when they harbored pathogenic organisms or high levels of commensal organisms. Univariate and multivariate logistic regression analyses were conducted to examine whether substantial conjunctival or lid bioburden, subject demographics, lens-wearing history, symptoms, and biomicroscopic signs were associated with lens bioburden.ResultsAbout one third (32.4%) of subjects had substantial bacterial bioburden in either eye across multiple visits. Over half (53.2%) and about one tenth (11.7%) of subjects had substantial lid and conjunctival bioburden, respectively, and 11.2% discontinued because of discomfort. The adjusted odds ratios (and 95% confidence intervals) for presence of substantial lens bioburden were 2.49 (1.17-5.30), 4.24 (1.45-12.40), and 4.11 (1.17-14.46) for substantial lid bioburden, substantial conjunctival bioburden, and lens discomfort, respectively.ConclusionsBacterial contamination of silicone hydrogel contact lenses is common during CW. Substantial lens bioburden is associated with discomfort precluding successful CW. The presence of substantial lid and conjunctival bioburden is associated with a 2.5-fold and more than fourfold greater risk of substantial lens bioburden and is likely the major route of contamination.

Project description:PurposeTo compare the subjective performances of verofilcon A daily disposable silicone hydrogel contact lenses (CLs) and etafilcon A hydrogel CLs.MethodsSuccessful wearers of spherical soft CLs for distance correction were prospectively randomized to wear verofilcon A or etafilcon A lenses for 1 week and crossed over to the alternative lenses. The primary study objective was a comparison of distance visual acuity (VA). Exploratory endpoints included subjective overall lens preference (5-point scale) and subjective ratings (10-point scales) of end-of-day (EOD) vision, overall handling, insertion comfort, EOD comfort, overall quality of vision, overall comfort, vision throughout the day, lens handling at insertion, and lens handling at removal.ResultsOf 92 subjects (184 eyes), 46 each were randomized to verofilcon A or etafilcon A lenses and subsequently crossed over to the other lenses. Evaluation of distance VA showed that verofilcon A lenses were noninferior to etafilcon A lenses. Comparison of lens preference showed that 68 (73.9%) subjects somewhat or strongly preferred verofilcon A lenses, whereas 21 (22.9%) somewhat or strongly preferred etafilcon A lenses (p<0.0001). Mean ± SD ratings of EOD vision (8.6±1.5 vs 7.7±1.9), overall handling (8.7±1.5 vs 6.9±2.3), insertion comfort (9.2±1.0 vs 7.7±1.9), and EOD comfort (8.0±1.9 vs 7.0±2.2) were all significantly (p≤0.0001 each) higher for verofilcon A than for etafilcon A lenses. Mean ± SD ratings of overall quality of vision (8.9±1.2 vs 8.2±1.8), overall comfort (8.6±1.5 vs 7.4±1.8), vision throughout the day (8.9±1.3 vs 8.1±1.8), lens handling at insertion (9.0±1.4 vs 6.9±2.5), and lens handling at removal (8.3±2.1 vs 7.7±2.2) were also significantly higher for verofilcon A lenses. No subject experienced any ocular adverse events.ConclusionAfter 1 week of wear, the study population reported that ratings for subjective endpoints were significantly higher for verofilcon A lenses than for etafilcon A lenses.

Dataset Information

Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses.

Publications

Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure