Michael J Lipson1, Alan Sugar, David C Musch. 1. Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan, USA. mjlipson@umich.edu
Abstract
PURPOSE: The purpose of this article is to evaluate patients' visual acuity, symptoms, and perceptions of vision-related quality of life in a randomized crossover clinical trial of overnight corneal reshaping (OCR) and daily wear soft lenses (SCL). METHODS:Qualified subjects were randomly assigned to wear one mode of contact lens for 8 weeks and then, after a washout period, they wore the alternate mode for 8 weeks. On concluding each contact lens wear mode, subjects completed the NEI-RQL42 questionnaire. During the SCL mode, subjects wore lenses during their waking hours. During the OCR mode, subjects wore lenses only while sleeping. Soft lenses were Biomedics 55 2-week disposable lenses. OCR lenses were CRT lenses by Paragon. (Three subjects were fit with custom-designed OCR lenses in Boston XO material, manufactured by Art Optical.) LogMAR acuity was measured and slit lamp evaluation was performed at specified intervals during follow up. After completing both phases of the study, patients chose which mode they preferred. RESULTS: Of 81 enrolled patients, 65 completed both phases and 16 dropped out during the study. Significant differences (p<0.01) favoring SCL wear included better visual acuity and less trouble with glare. Significant differences (p<0.01) favoring OCR wear included less activity limitations, less trouble with symptoms, and less dependence on refractive correction. Of 65 completing both phases, 44 preferred the OCR lenses and 21 preferred the soft lenses. Subjects who preferred the OCR lenses were less myopic and had steeper K readings at baseline, and showed less difference between visual acuity during OCR wear and visual acuity with SCL. CONCLUSION: In subjects with mild myopia who experienced both SCL and OCR, better visual acuity and less glare resulted from SCL wear, whereas activity limitations, symptoms, and dependence on refractive correction were less troublesome with OCR wear. When the study was completed, 67.7% chose OCR lenses worn only while sleeping, whereas 32.3% preferred 2-week disposable soft lenses worn during the day as their preferred correction.
RCT Entities:
PURPOSE: The purpose of this article is to evaluate patients' visual acuity, symptoms, and perceptions of vision-related quality of life in a randomized crossover clinical trial of overnight corneal reshaping (OCR) and daily wear soft lenses (SCL). METHODS: Qualified subjects were randomly assigned to wear one mode of contact lens for 8 weeks and then, after a washout period, they wore the alternate mode for 8 weeks. On concluding each contact lens wear mode, subjects completed the NEI-RQL42 questionnaire. During the SCL mode, subjects wore lenses during their waking hours. During the OCR mode, subjects wore lenses only while sleeping. Soft lenses were Biomedics 55 2-week disposable lenses. OCR lenses were CRT lenses by Paragon. (Three subjects were fit with custom-designed OCR lenses in Boston XO material, manufactured by Art Optical.) LogMAR acuity was measured and slit lamp evaluation was performed at specified intervals during follow up. After completing both phases of the study, patients chose which mode they preferred. RESULTS: Of 81 enrolled patients, 65 completed both phases and 16 dropped out during the study. Significant differences (p<0.01) favoring SCL wear included better visual acuity and less trouble with glare. Significant differences (p<0.01) favoring OCR wear included less activity limitations, less trouble with symptoms, and less dependence on refractive correction. Of 65 completing both phases, 44 preferred the OCR lenses and 21 preferred the soft lenses. Subjects who preferred the OCR lenses were less myopic and had steeper K readings at baseline, and showed less difference between visual acuity during OCR wear and visual acuity with SCL. CONCLUSION: In subjects with mild myopia who experienced both SCL and OCR, better visual acuity and less glare resulted from SCL wear, whereas activity limitations, symptoms, and dependence on refractive correction were less troublesome with OCR wear. When the study was completed, 67.7% chose OCR lenses worn only while sleeping, whereas 32.3% preferred 2-week disposable soft lenses worn during the day as their preferred correction.
Authors: Nery García-Porta; Laura Rico-Del-Viejo; Alba Martin-Gil; Gonzalo Carracedo; Jesus Pintor; José Manuel González-Méijome Journal: Biomed Res Int Date: 2016-08-31 Impact factor: 3.411