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May. 24, 2019

June. 01, 2022

jRCTs032190029

Effectiveness of the progressive contact lenses for asthenopia patients (Effectiveness of the progressive contact lenses for asthenopia)

Effectiveness of the progressive contact lenses for asthenopia patients (Effectiveness of the progressive contact lenses for asthenopia patients)

Mar. 24, 2021

33

Average age: 31 years (The mean age of the 10 participants whose subjective symptoms were better with monofocal contact lenses (hereafter the monofocal CL group) was 33.5 years, and the mean age of the 20 participants whose subjective symptoms were better with +0.5D-addition CL (hereafter the +0.5D-addition CL group) was 30 years.) Sex: 25 females and 5 males (Seven females and 3 males in the monofocal CL group, 18 females and 2 males in the +0.5D-addition CL group)

Thirty-three subjects participated in the study, and 30 participants completed the protocol. All 30 participants completed the protocol.

None

The primary endpoint was the VAS score for three symptoms: "tired eye," "discomfort feeling at the surface of the eye," and "blurry vision". There was no significant difference in VAS scores between participants using monofocal CL and those using +0.5D-addition CL for any of the symptoms. At the end of the study, 20 patients chose to receive +0.5D-addition CL and 10 patients chose a monofocal CL. There was no significant difference in the clinical characteristics of the two groups.

We compared the effects of a +0.5D-addition CL and monofocal CL on eye strain symptoms in 33 young people. Of the 30 subjects who completed the study, there was no significant difference in the symptoms of eye strain between the two types of CLs. However, in the questionnaire at the end of the study,

June. 01, 2022

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190029

Ohno-Matsui Kyoko

Tokyo Medical and Dental University, Medical Hospital

1-5-45,Yushima,Bunkyo, Tokyo

+81-3-5803-5311

k.ohno.oph@tmd.ac.jp

Iwasaki Yuko

Tokyo Medical and Dental University, Medical Hospital

1-5-45,Yushima,Bunkyo, Tokyo

+81-3-5803-5311

sahnya96@gmail.com

Complete

May. 09, 2019

40

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

1.Age: 20 to 40
2.Sex: Man and woman
3.Patients who can wear soft CL more than five days a week, and more than eight hours a day
4.Patients who are usually using single focus software CL
5.Patients who is awareness of asthenopia
6.Patients shall have at least 1.0 of distance vision for each eye with best correction
7.Patients who gives written informed consent voluntarily, before enrolling the study

1.Patients who have anterior eye diseases and are not able to wear soft CL (e.g.: Dry eye)
2.Patient who use other types CL (e.g.: Hard CL, Ortho-Keratology CL)
3.Patients who received cornea refractive surgery
4.Patients who received cataract surgery
5.Patients who are suffer from systemic diseases
6.Patients who are pregnant or breastfeeding
7.Patients who take medicines or supplement that would influence accommodation amplitude
8.Patients who are judged as unsuitable for this study by investigator.

20age old over
40age old under

Both

asthenopia

The patient uses single focus CL and low grade progressive CL. Trial period is two weeks for each CL. The patients use CL with randomly assigned order.

The degree of asthenopia symptom

Clinical evaluation (e.g. amplitude of accommodation, accommodative microfluctuations, eye position)

SEED CO., LTD.
Not applicable
Tokyo Medical and Dental University Research Review Board
, Tokyo

+81-3-5803-4575

mkan-rinsho.adm@cmn.tmd.ac.jp
Approval

Mar. 22, 2019

none

History of Changes

No Publication date
4 June. 01, 2022 (this page) Changes
3 Jan. 20, 2021 Detail Changes
2 June. 19, 2020 Detail Changes
1 May. 24, 2019 Detail