Alicia Ruiz-Pomeda1, Belén Pérez-Sánchez2, Pilar Cañadas3, Francisco Luis Prieto-Garrido4, Ramón Gutiérrez-Ortega5, César Villa-Collar6. 1. Faculty of Biomedical and Health Sciences, Department of Pharmacy, Biotechnology, Nutrition, 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, Alacant, Spain. 3. Ocular Surface Group. Institute of Applicate Opthalmobiology (IOBA), Department of Theoretical Physics, Atomic and Optic, University of Valladolid, Valladolid, Spain. 4. Department Optics I: Optometry and Vision, Universidad Complutense de Madrid, Madrid, Spain. 5. Clínica oftalmológica Novovisión, Madrid, Spain. 6. Faculty of Biomedical and Health Sciences, Department of Pharmacy, Biotechnology, Nutrition, Optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.
Abstract
PURPOSE: To evaluate the binocular and accommodative function in children wearing dual focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single-vision (SV) spectacles. METHODS: This was a randomized, controlled clinical trial involving subjects aged 8 to 12, with myopia ranging from - 0.75 to - 4.00D and astigmatism < 1.00D, allocated toMiSight® study CLs group or control group wearing SV. Binocular and accommodative function was determined at baseline, 12-, and 24-month visits, assessed by the following sequence of tests: distance and near horizontal phoria, accommodative convergence/accommodation (AC/A) ratio, stereopsis, accommodative amplitude (AA), and accommodative response (AR) at 33, 25 and 20 cm. RESULTS:Seventy-four children completed the study: 41 in the CL group and 33 in the SV group. CLs group did not show any significant differences in binocular and accommodative measurements throughout the study. In control group, distance and near phoria, stereopsis, AC/A and AR at 20 cm did not show any significant change, but AA, AR at 33 cm and AR at 25 cm were greater at 24-month visit compared with baseline (p < 0.05). CONCLUSIONS: DF lenses do not change the binocular and accommodative function in children wearing dual focus CLs. TRIAL REGISTRATION: NCT01917110.
RCT Entities:
PURPOSE: To evaluate the binocular and accommodative function in children wearing dual focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single-vision (SV) spectacles. METHODS: This was a randomized, controlled clinical trial involving subjects aged 8 to 12, with myopia ranging from - 0.75 to - 4.00D and astigmatism < 1.00D, allocated to MiSight® study CLs group or control group wearing SV. Binocular and accommodative function was determined at baseline, 12-, and 24-month visits, assessed by the following sequence of tests: distance and near horizontal phoria, accommodative convergence/accommodation (AC/A) ratio, stereopsis, accommodative amplitude (AA), and accommodative response (AR) at 33, 25 and 20 cm. RESULTS: Seventy-four children completed the study: 41 in the CL group and 33 in the SV group. CLs group did not show any significant differences in binocular and accommodative measurements throughout the study. In control group, distance and near phoria, stereopsis, AC/A and AR at 20 cm did not show any significant change, but AA, AR at 33 cm and AR at 25 cm were greater at 24-month visit compared with baseline (p < 0.05). CONCLUSIONS: DF lenses do not change the binocular and accommodative function in children wearing dual focus CLs. TRIAL REGISTRATION: NCT01917110.
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