Clinical study on the effect of multifocal contact lenses on myopia progression in myopia school children : Multifocal contact lens study for suppression of myopia progression. 2021

Osamu Hieda, and Yo Nakamura, and Takahiro Hiraoka, and Miho Kojima, and Tetsuro Oshika, and Chie Sotozono
Department of Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan. ohieda@koto.kpu-m.ac.jp.

BACKGROUND The efficacy of peripheral low add multifocal soft contact lenses (SCLs) for suppressing the progression of myopia is controversial. The aim of the on-going present clinical study is to investigate whether or not multifocal SCLs with + 0.50 diopters (D) addition suppress the progression of myopia in myopic elementary school children. METHODS Prospective randomized controlled trial. METHODS The study plans to include a total of 100 myopic school children. Target subjects are primary school male and female students with mild to moderate myopia. Children who have eye-related diseases other than myopia are excluded from the study, because they may affect the evaluation of the outcome. Subjects will be randomly assigned to wear daily disposable multifocal contact lenses with + 0.50D addition or daily disposable SCLs. Subjects will wear contact lenses on both eyes and will be observed for 2 years under a double-masked examination. Primary outcome is a change in the axial length over the 2-year period. OBJECTIVE The purpose of this study is to identify whether or not multifocal SCLs with + 0.5D addition suppress the progression of myopia in myopic elementary school children as compared with standard SCLs. BACKGROUND 1. UMIN (University Hospital Medical Information Network) UMIN000027940. Registered on July 21, 2017 2. JRCT (Japan Registry of Clinical Trials) jRCTs052180172. Registered on March 26, 2019.

UI MeSH Term Description Entries
D007564 Japan A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo. Bonin Islands
D008297 Male Males
D009216 Myopia A refractive error in which rays of light entering the EYE parallel to the optic axis are brought to a focus in front of the RETINA when accommodation (ACCOMMODATION, OCULAR) is relaxed. This results from an overly curved CORNEA or from the eyeball being too long from front to back. It is also called nearsightedness. Nearsightedness,Myopias,Nearsightednesses
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D003261 Contact Lenses Lenses designed to be worn on the front surface of the eyeball. (UMDNS, 1999) Lenses, Contact,Contact Lens,Lens, Contact
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012574 Schools Educational institutions. Primary Schools,Schools, Secondary,Secondary Schools,Primary School,School,School, Primary,School, Secondary,Schools, Primary,Secondary School
D018450 Disease Progression The worsening and general progression of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis. Clinical Course,Clinical Progression,Disease Exacerbation,Exacerbation, Disease,Progression, Clinical,Progression, Disease

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