Paul Chamberlain, Sofia C Peixoto-de-Matos1, Nicola S Logan2, Cheryl Ngo3, Deborah Jones4, Graeme Young5. 1. Clinical and Experimental Optometry Research Lab, Centre of Physics, School of Sciences, University of Minho, Braga, Portugal. 2. Ophthalmic Research Group, School of Optometry, Aston University, Aston Triangle, Birmingham, United Kingdom. 3. Department of Ophthalmology, National University Hospital, Singapore. 4. Centre for Ocular Research and Education, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada. 5. Visioncare Research Ltd., Farnham, Surrey, United Kingdom.
Abstract
SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS:Myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (-0.51 ± 0.64 vs. -1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = -0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.
RCT Entities:
SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS: Myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (-0.51 ± 0.64 vs. -1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = -0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.
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: Andrzej Malinowski; Małgorzata Mrugacz; Marcin Stopa; Erita Filipek; Anna Moniuszko-Malinowska; Piotr Czupryna Journal: Clin Ophthalmol Date: 2022-01-11
Authors: Paul Chamberlain; Percy Lazon de la Jara; Baskar Arumugam; Mark A Bullimore Journal: Ophthalmic Physiol Opt Date: 2021-05-05 Impact factor: 3.117
Authors: Loretta B Szczotka-Flynn; Joseph P Shovlin; Cristina M Schnider; Barbara E Caffery; Eduardo C Alfonso; Nicole A Carnt; Robin L Chalmers; Sarah Collier; Deborah S Jacobs; Charlotte E Joslin; Abby R Kroken; Carol Lakkis; Eric Pearlman; Oliver D Schein; Fiona Stapleton; Elmer Tu; Mark D P Willcox Journal: Optom Vis Sci Date: 2021-03-01 Impact factor: 2.106
Authors: Hannah R Gregory; Augustine N Nti; James S Wolffsohn; David A Berntsen; Eric R Ritchey Journal: Optom Vis Sci Date: 2021-03-01 Impact factor: 2.106