PURPOSE: This study evaluates lens care using the PuriLens System, an advanced way to clean and disinfect soft hydrophilic lenses using subsonic agitation and UV radiation, respectively. METHODS: A two-period crossover lens cleaning and safety investigation was conducted using 80 patients. Disinfecting efficacy was tested in accordance with standard FDA protocols. Lens compatibility was studied with Group I and Group IV lenses during the equivalent of a 6-month care regimen by measuring: lens power, base curve, wet diameter, refractive index, clarity, and tint. Safety was evaluated through slit-lamp findings, wearing time, comfort, and visual acuity. RESULTS: The mean wearing time of patients in the study was 13.79 hours. No slit lamp findings greater than grade 2 were noted. Visual acuity was 20/25 or better in 92.5% of examinations. None of the patients lost more than two lines of acuity. Lens surface evaluation showed no deposits (grade 0) to very slight deposits (grade 1) in 94.4% of examinations. Lenses cleaned with the PuriLens System were cleaner by a statistically significant margin (P=0.02) compared to lenses digitally cleaned with a leading multi-purpose solution (ReNu, Bausch & Lomb). Overall, neither the Group I nor Group IV lenses were affected after 180 cleaning cycles. CONCLUSIONS: The PuriLens System provides automatic lens care compliance, superior antimicrobial efficacy, and eliminates the need for daily digital cleaning.
RCT Entities:
PURPOSE: This study evaluates lens care using the PuriLens System, an advanced way to clean and disinfect soft hydrophilic lenses using subsonic agitation and UV radiation, respectively. METHODS: A two-period crossover lens cleaning and safety investigation was conducted using 80 patients. Disinfecting efficacy was tested in accordance with standard FDA protocols. Lens compatibility was studied with Group I and Group IV lenses during the equivalent of a 6-month care regimen by measuring: lens power, base curve, wet diameter, refractive index, clarity, and tint. Safety was evaluated through slit-lamp findings, wearing time, comfort, and visual acuity. RESULTS: The mean wearing time of patients in the study was 13.79 hours. No slit lamp findings greater than grade 2 were noted. Visual acuity was 20/25 or better in 92.5% of examinations. None of the patients lost more than two lines of acuity. Lens surface evaluation showed no deposits (grade 0) to very slight deposits (grade 1) in 94.4% of examinations. Lenses cleaned with the PuriLens System were cleaner by a statistically significant margin (P=0.02) compared to lenses digitally cleaned with a leading multi-purpose solution (ReNu, Bausch & Lomb). Overall, neither the Group I nor Group IV lenses were affected after 180 cleaning cycles. CONCLUSIONS: The PuriLens System provides automatic lens care compliance, superior antimicrobial efficacy, and eliminates the need for daily digital cleaning.