Carole Maldonado-Codina1, Nathan Efron. 1. Eurolens Research, Department of Optometry and Neuroscience, UMIST, Manchester, United Kingdom. carole.m-codine@umist.ac.uk
Abstract
PURPOSE: To establish the clinical impact of three different methods of manufacture used to produce soft contact lenses. METHODS: Clinical performance of five lens types was investigated by undertaking a prospective, double-masked, randomized, crossover study. Three of the lenses were made from poly(hydroxyethyl methacrylate) (pHEMA) by three different manufacturing processes (lathing, spin casting, and cast molding), and the remaining two lenses were cast molded from different materials-hydroxyethyl methacrylate/methacrylic acid and hydroxyethyl methacrylate/glycerol methacrylate (HEMA/GMA). All lenses were specially fabricated for this work at the same manufacturing plant. Thirty-four soft contact lens wearers wore each lens for 1 month on a daily-wear basis. Several clinical variables, such as ocular response, visual acuity, lens fitting, prelens tear film, lens surface dehydration, subjective response, and protein deposition, were measured. RESULTS: In general, the spun-cast pHEMA lens performed inferiorly compared with the other pHEMA lenses. This lens induced significantly more limbal and conjunctival hyperemia than the cast-molded lens and provided poorer low contrast visual acuity (LCVA) than the other two lenses. It dehydrated more and had the least on-eye movement. However, the spun-cast lens deposited the least protein of the pHEMA lenses. In general, the HEMA/GMA lens performed inferiorly compared with the other cast-molded lenses. LCVA was worse with this lens, and subjective responses showed that this lens was thought to give the worst visual performance of the cast-molded lenses. It was also thought to be the most difficult lens to handle. Significantly more breakages occurred with this lens than any other. CONCLUSIONS: Overall, this work has shown that manufacturing method and material composition have a fundamental effect on many clinical properties of a lens. Therefore, method of manufacture is also an important consideration in the overall production of a soft lens.
RCT Entities:
PURPOSE: To establish the clinical impact of three different methods of manufacture used to produce soft contact lenses. METHODS: Clinical performance of five lens types was investigated by undertaking a prospective, double-masked, randomized, crossover study. Three of the lenses were made from poly(hydroxyethyl methacrylate) (pHEMA) by three different manufacturing processes (lathing, spin casting, and cast molding), and the remaining two lenses were cast molded from different materials-hydroxyethyl methacrylate/methacrylic acid and hydroxyethyl methacrylate/glycerol methacrylate (HEMA/GMA). All lenses were specially fabricated for this work at the same manufacturing plant. Thirty-four soft contact lens wearers wore each lens for 1 month on a daily-wear basis. Several clinical variables, such as ocular response, visual acuity, lens fitting, prelens tear film, lens surface dehydration, subjective response, and protein deposition, were measured. RESULTS: In general, the spun-cast pHEMA lens performed inferiorly compared with the other pHEMA lenses. This lens induced significantly more limbal and conjunctival hyperemia than the cast-molded lens and provided poorer low contrast visual acuity (LCVA) than the other two lenses. It dehydrated more and had the least on-eye movement. However, the spun-cast lens deposited the least protein of the pHEMA lenses. In general, the HEMA/GMA lens performed inferiorly compared with the other cast-molded lenses. LCVA was worse with this lens, and subjective responses showed that this lens was thought to give the worst visual performance of the cast-molded lenses. It was also thought to be the most difficult lens to handle. Significantly more breakages occurred with this lens than any other. CONCLUSIONS: Overall, this work has shown that manufacturing method and material composition have a fundamental effect on many clinical properties of a lens. Therefore, method of manufacture is also an important consideration in the overall production of a soft lens.