PURPOSE: A four-month extended wear clinical trial was conducted to compare the ocular effects of a high Dk Balafilcon A silicone hydrogel lens and a low Dk HEMA 38.6 per cent H20 soft lens. METHOD: Twenty-four subjects who were adapted to daily wear ofsoft lenses wore a high Dk lens in one eye and a low Dk HEMA lens in the other eye for four months on an extended wear basis after one week of daily wear. Thirteen progress evaluations were conducted using standard clinical procedures. RESULTS:Eighteen subjects (75 per cent) completed the study. The high Dk lens induced significantly less bulbar and limbal injection and corneal vascularisation than the low Dk HEMA lens (p < 0.05). Epithelial microcysts were observed only in the eyes wearing the low Dk lens. A significant increase in myopia was found in the eyes wearing the low Dk HEMA lens (mean = 0.50 D, p < 0.01) compared to the insignificant myopic increase of 0.06 D in the eyes wearing the high Dk lens. Three subjects developed small infiltrates in the high Dk lens wearing eyes and significantly more post-lens debris was observed under the high Dk lens. Six subjects developed papillary conjunctivitis in the eye wearing silicone hydrogel lenses but only two of those were discontinued from the study. CONCLUSION: No hypoxia-related effects were observed with extended wear of the high Dk Balafilcon A silicone hydrogel lens.
RCT Entities:
PURPOSE: A four-month extended wear clinical trial was conducted to compare the ocular effects of a high Dk Balafilcon Asilicone hydrogel lens and a low Dk HEMA 38.6 per cent H20 soft lens. METHOD: Twenty-four subjects who were adapted to daily wear of soft lenses wore a high Dk lens in one eye and a low Dk HEMA lens in the other eye for four months on an extended wear basis after one week of daily wear. Thirteen progress evaluations were conducted using standard clinical procedures. RESULTS: Eighteen subjects (75 per cent) completed the study. The high Dk lens induced significantly less bulbar and limbal injection and corneal vascularisation than the low Dk HEMA lens (p < 0.05). Epithelial microcysts were observed only in the eyes wearing the low Dk lens. A significant increase in myopia was found in the eyes wearing the low Dk HEMA lens (mean = 0.50 D, p < 0.01) compared to the insignificant myopic increase of 0.06 D in the eyes wearing the high Dk lens. Three subjects developed small infiltrates in the high Dk lens wearing eyes and significantly more post-lens debris was observed under the high Dk lens. Six subjects developed papillary conjunctivitis in the eye wearing silicone hydrogel lenses but only two of those were discontinued from the study. CONCLUSION: No hypoxia-related effects were observed with extended wear of the high Dk Balafilcon Asilicone hydrogel lens.