PURPOSE: To evaluate the performance of a silicone hydrogel daily disposable lens in neophyte subjects over 12 months. METHODS:Seventy four subjects with no previous contact lens experience were randomised to wear narafilcon A (1 DAY ACUVUE(®) TruEye™) lenses (LW group) or to wear no contact lenses (NLW group) for 12 months. Biomicroscopy (performed by a masked investigator), visual acuity and subjective response scores were recorded at an initial visit and six follow-up visits, in addition to lens fit and surface evaluation for the LW group. Comfort was recorded with SMS messaging. RESULTS: Fifteen of the LW group discontinued before the end of the study, compared with six of the NLW group. Measured visual acuity was about half a line better for the NLW group as these subjects were provided with their full sphero-cylindrical over-refraction, compared to the LW group in their best spherical corrected contact lenses; subjective scores for vision were similar for the two groups. Bulbar conjunctival hyperaemia, limbal hyperaemia, corneal staining, conjunctival staining and papillary conjunctivitis were clinically equivalent for the two groups whereas conjunctival staining was higher in the LW group. Comfort scores assessed by SMS were equivalent for the LW and NLW groups; there was a measurable improvement in comfort during the first month of wear for the LW group. CONCLUSION: This work has demonstrated that modern soft lenses (narafilcon A daily disposable silicone hydrogel lenses) offer an excellent, comfortable form of vision correction, and are able to exhibit minimal alterations to ocular physiology.
RCT Entities:
PURPOSE: To evaluate the performance of a silicone hydrogel daily disposable lens in neophyte subjects over 12 months. METHODS: Seventy four subjects with no previous contact lens experience were randomised to wear narafilcon A (1 DAY ACUVUE(®) TruEye™) lenses (LW group) or to wear no contact lenses (NLW group) for 12 months. Biomicroscopy (performed by a masked investigator), visual acuity and subjective response scores were recorded at an initial visit and six follow-up visits, in addition to lens fit and surface evaluation for the LW group. Comfort was recorded with SMS messaging. RESULTS: Fifteen of the LW group discontinued before the end of the study, compared with six of the NLW group. Measured visual acuity was about half a line better for the NLW group as these subjects were provided with their full sphero-cylindrical over-refraction, compared to the LW group in their best spherical corrected contact lenses; subjective scores for vision were similar for the two groups. Bulbar conjunctival hyperaemia, limbal hyperaemia, corneal staining, conjunctival staining and papillary conjunctivitis were clinically equivalent for the two groups whereas conjunctival staining was higher in the LW group. Comfort scores assessed by SMS were equivalent for the LW and NLW groups; there was a measurable improvement in comfort during the first month of wear for the LW group. CONCLUSION: This work has demonstrated that modern soft lenses (narafilcon A daily disposable silicone hydrogel lenses) offer an excellent, comfortable form of vision correction, and are able to exhibit minimal alterations to ocular physiology.
Authors: Nery García-Porta; Laura Rico-del-Viejo; Helena Ferreira-Neves; Sofia C Peixoto-de-Matos; Antonio Queirós; José M González-Méijome Journal: Biomed Res Int Date: 2015-03-31 Impact factor: 3.411