Xiaolin Zhang1, Christine Marchetti1, Jessica Lee1, Yan Sun1, Sara Debanne2, Ying Jiang2, Jami Kern3, Mark Harrod1, Beth Ann Benetz1, Eric Pearlman4, Loretta Szczotka-Flynn5. 1. Department of Ophthalmology & Visual Sciences and University Hospitals Eye Institute, University Hospitals Case Medical Center, Cleveland, OH, United States. 2. Department of Epidemiology & Biostatistics, Case Western Reserve University, Cleveland, OH, United States. 3. Alcon Research, Fort Worth, TX, United States. 4. Department of Ophthalmology & Visual Sciences and University Hospitals Eye Institute, University Hospitals Case Medical Center, Cleveland, OH, United States; Department of Ophthalmology, University of California, Irvine, United States. 5. Department of Ophthalmology & Visual Sciences and University Hospitals Eye Institute, University Hospitals Case Medical Center, Cleveland, OH, United States. Electronic address: loretta.szczotka@uhhospitals.org.
Abstract
PURPOSE: To assess corneal epithelial microstructure via confocal microscopy and determine if cellular changes are associated with lens care solutions during daily wear of silicone hydrogel contact lenses. METHODS: Corneal in vivo confocal microscopy with the Nidek ConfoScan4 was performed at baseline and after 5 months of lotrafilcon A daily contact lens wear. Enrolled participants were randomized to use either a polyhexamethylene biguanide (PHMB) preserved multipurpose care solution (MPS) or a peroxide based solution system. Lens and storage case bioburden were assessed with aerobic culture methods. Univariate and multivariable analyses were done to evaluate the association between solution use, or solution-related clinical covariates, and morphologic differences (hyper-reflectivity) in the superficial epithelial cells and epithelial basal cell density. RESULTS: Data on 139 participants were available for analysis of superficial epithelial cells while data on 92 participants were available for epithelial basal cell density. Five months after randomization to the solution groups, 33% of participants had visible hyper-reflective cells. More participants using MPS had ≥1 hyper-reflective cells compared to peroxide users at 5 months (44% vs. 22%; p=0.006). Similarly at 5 months, more participants with solution-induced corneal staining (SICS) had ≥1 hyper-reflective cells compared to non-SICS participants (57% vs. 29%; p=0.010). The adjusted odds ratios (ORs) for risk of presenting with hyper-reflective cells in MPS users or SICS participants was 2.7 (95% CI; 1.27-5.65) and 3.4 (95% CI; 1.29-8.97), respectively. Basal cell density decreased by over 350 cells/mm2 over time (about 6%) in participants who had substantial bioburden on their lenses or in their storage case. CONCLUSION: The confocal microscope can detect epithelial cellular changes in vivo during contact lens wear. Hyper-reflective superficial epithelial cells are associated with a PHMB preserved solution and decreases in basal epithelial cell density may be associated with bacterial bioburden.
RCT Entities:
PURPOSE: To assess corneal epithelial microstructure via confocal microscopy and determine if cellular changes are associated with lens care solutions during daily wear of silicone hydrogel contact lenses. METHODS: Corneal in vivo confocal microscopy with the Nidek ConfoScan4 was performed at baseline and after 5 months of lotrafilcon A daily contact lens wear. Enrolled participants were randomized to use either a polyhexamethylene biguanide (PHMB) preserved multipurpose care solution (MPS) or a peroxide based solution system. Lens and storage case bioburden were assessed with aerobic culture methods. Univariate and multivariable analyses were done to evaluate the association between solution use, or solution-related clinical covariates, and morphologic differences (hyper-reflectivity) in the superficial epithelial cells and epithelial basal cell density. RESULTS: Data on 139 participants were available for analysis of superficial epithelial cells while data on 92 participants were available for epithelial basal cell density. Five months after randomization to the solution groups, 33% of participants had visible hyper-reflective cells. More participants using MPS had ≥1 hyper-reflective cells compared to peroxide users at 5 months (44% vs. 22%; p=0.006). Similarly at 5 months, more participants with solution-induced corneal staining (SICS) had ≥1 hyper-reflective cells compared to non-SICSparticipants (57% vs. 29%; p=0.010). The adjusted odds ratios (ORs) for risk of presenting with hyper-reflective cells in MPS users or SICS participants was 2.7 (95% CI; 1.27-5.65) and 3.4 (95% CI; 1.29-8.97), respectively. Basal cell density decreased by over 350 cells/mm2 over time (about 6%) in participants who had substantial bioburden on their lenses or in their storage case. CONCLUSION: The confocal microscope can detect epithelial cellular changes in vivo during contact lens wear. Hyper-reflective superficial epithelial cells are associated with a PHMB preserved solution and decreases in basal epithelial cell density may be associated with bacterial bioburden.