NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200118

Registered date:14/09/2020

Performance of Extended Depth of Focus (EDOF) multifocal SCL for intraocular lens implanted eyes

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedIOL implanted eyes after cataract surgery
Date of first enrollment10/10/2020
Target sample size17
Countries of recruitment
Study typeInterventional
Intervention(s)Multifocal soft contact lens

Outcome(s)

Primary OutcomeVisual acuity at various distances at contrast sensitivity of 100%
Secondary Outcome- Visual acuity at various distances at contrast sensitivity of 40% and 20% - Visual acuity at far and near in open filed - Contrast sensitivity with stripe vision chart - Stereopsis

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria-Men and women who understand the contents of the consent explanation document and their informed consents can be obtained. -Those whose ages are between 20 and 75 -Those who had undergone cataract surgery 1 month ago or before -Those who have monofocal or toric intraocular lenses inserted in both eyes -Those have spherical equivalent from 0.00 to -6.00D by refraction test -Those who require near or far vision correction -Those who have a total astigmatism of 1.00D or less in both eyes by refraction test -Those who have corrected distance vision in both eyes of 0.7 or better (decimal visual acuity)
Exclude criteria- Patients with moderate or severe grade of corneal/conjunctival or eyelid abnormalities - Patients with uveitis - Patients with dry eye and lacrimal disease that are problematic for lens wear - Patients with allergic diseases that can affect lens wear - Patients with diabetics - Patients with a history of anaphylaxis - Patients with serious cardiac, hepatic, renal, pulmonary, hematological disorders and other complications that are considered inappropriate for the study. - Patients who have participated in other trials within the last 3 months - Pregnant women, women who are breastfeeding or plan to become pregnant during the study - Patients who used hard contact lens (including Orthokeratology lens) within the last 1 month - Patients who wear contact lenses in 1 eye only. - Patients who are judged to be ineligible for the study by the investigators and those are considered unsuitable for wearing soft contact lenses by the investigators.

Related Information

Contact

Public contact
Name Hiraoka Takahiro
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3148
E-mail thiraoka@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Hiraoka Takahiro
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3148
E-mail thiraoka@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital