Alicia Ruiz-Pomeda1, Belén Pérez-Sánchez2, Isabel Valls3, Francisco Luis Prieto-Garrido4, Ramón Gutiérrez-Ortega3, César Villa-Collar5. 1. Department of Pharmacy, Biotechnology, Optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. alicia.ruiz@universidadeuropea.es. 2. Department of Statistics, Mathematics and Informatics. Area of Languages and Computer Systems, Miguel Hernández University of Elche, Elche, Alicante, Spain. 3. Clínica oftalmológica Novovision, Madrid, Spain. 4. Department Optics I: Optometry and Vision, Universidad Complutense de Madrid, Madrid, Spain. 5. Doctoral and Research School, European University of Madrid, Madrid, Spain.
Abstract
PURPOSE: To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period. METHODS:Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits. RESULTS:Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use. CONCLUSIONS:MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.
RCT Entities:
PURPOSE: To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period. METHODS: Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits. RESULTS: Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use. CONCLUSIONS: MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.
Authors: Stephan J Linke; Julio Baviera; Gur Munzer; Johannes Steinberg; Gisbert Richard; Toam Katz Journal: Invest Ophthalmol Vis Sci Date: 2011-11-25 Impact factor: 4.799
Authors: R Michael Siatkowski; Susan A Cotter; R S Crockett; Joseph M Miller; Gary D Novack; Karla Zadnik Journal: J AAPOS Date: 2008-03-24 Impact factor: 1.220
Authors: Francisco Luis Prieto-Garrido; Cesar Villa-Collar; Jose Luis Hernandez-Verdejo; Cristina Alvarez-Peregrina; Alicia Ruiz-Pomeda Journal: J Clin Med Date: 2022-07-01 Impact factor: 4.964
Authors: Jeffrey J Walline; Maria K Walker; Donald O Mutti; Lisa A Jones-Jordan; Loraine T Sinnott; Amber Gaume Giannoni; Katherine M Bickle; Krystal L Schulle; Alex Nixon; Gilbert E Pierce; David A Berntsen Journal: JAMA Date: 2020-08-11 Impact factor: 56.272
Authors: Jeffrey J Walline; Kristina B Lindsley; S Swaroop Vedula; Susan A Cotter; Donald O Mutti; Sueko M Ng; J Daniel Twelker Journal: Cochrane Database Syst Rev Date: 2020-01-13