María García-Montero1, Laura Rico-Del-Viejo2, Clara Llorens-Quintana3, Amalia Lorente-Velázquez2, Jose Luis Hernández-Verdejo2, David Madrid-Costa2. 1. Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain. Electronic address: mgarc01@ucm.es. 2. Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain. 3. Department of Biomedical Engineering, Faculty of Fundamental Problems of Technology, Wroclaw University of Science and Technology, Wroclaw, Poland.
Abstract
PURPOSE: The aim of the current study is to assess, using new technologies, the interaction of four monthly silicone hydrogel contact lenses on the ocular surface and the comfort over 15 days of use. METHODS: Prospective cross-over, randomized and double-masked study including four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3). Clinical examination was performed in the following order: tear meniscus height, first break-up of the tear film, the average time of all tear film breakup incidents, bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining. Finally, subjective comfort was obtained from Contact Lens Dry Eye Questionnaire-8. RESULTS: The impact of contact lens wear on the ocular surface didn't show statistically significant changes over time except for corneal and conjunctival staining grades on day 15 compared to day 1 for the comfilcon A group (P = .003 and P = .01, respectively). Contact lens stability and impact on the ocular surface during contact lens wear didn't show statistically significant changes over time except in the case of the comfilcon A material with respect to the irritation item (P = .01). CONCLUSIONS: These results suggest that the impact of monthly silicone hydrogel contact lens materials on the ocular surface after and during contact lens wear, contact lens stability over time, and subjective comfort did not reveal any significant changes over 15 days of use for any of the materials.
RCT Entities:
PURPOSE: The aim of the current study is to assess, using new technologies, the interaction of four monthly silicone hydrogel contact lenses on the ocular surface and the comfort over 15 days of use. METHODS: Prospective cross-over, randomized and double-masked study including four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3). Clinical examination was performed in the following order: tear meniscus height, first break-up of the tear film, the average time of all tear film breakup incidents, bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining. Finally, subjective comfort was obtained from Contact Lens Dry Eye Questionnaire-8. RESULTS: The impact of contact lens wear on the ocular surface didn't show statistically significant changes over time except for corneal and conjunctival staining grades on day 15 compared to day 1 for the comfilcon A group (P = .003 and P = .01, respectively). Contact lens stability and impact on the ocular surface during contact lens wear didn't show statistically significant changes over time except in the case of the comfilcon A material with respect to the irritation item (P = .01). CONCLUSIONS: These results suggest that the impact of monthly silicone hydrogel contact lens materials on the ocular surface after and during contact lens wear, contact lens stability over time, and subjective comfort did not reveal any significant changes over 15 days of use for any of the materials.