UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034887
Receipt number R000039703
Scientific Title Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens
Date of disclosure of the study information 2018/12/01
Last modified on 2020/11/15 22:11:34

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Basic information

Public title

Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens

Acronym

Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens

Scientific Title

Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens

Scientific Title:Acronym

Assessment of Functional Visual Acuity on the Eyes with Multi Focal Soft Contact Lens

Region

Japan


Condition

Condition

Patients (40 to 49 years old) who notice Presbyopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to examine the relationship between the satisfaction level and the functional visual acuity of the wearers with multifocal soft contact lens by comparing the conventional VA with the functional visual acuity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparative evaluation of examination during wearing of two kinds of soft contact lenses

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

49 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who are aware of a decline in visual acuity of 40 to 49 years old
2) Single focal soft contact lens wearer who wants multifocal soft contact lens
3) Patients who can properly prescribe Lo
4)A patient who understands the contents of the consent document and is able to consent in the document of the person
5)Patient who can come to the observation day by the instruction of the researcher

Key exclusion criteria

1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye
2)Patients who have allergy and infectious ocular conditions.
3)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research
4)Patients judged by other research managers or researchers as inappropriate to implement this research safely

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Suzuki

Organization

Ishizuchi Eye Clinic

Division name

Director

Zip code

7920811

Address

1-8-30 Shonaicho Niihama-city Ehime

TEL

0897333069

Email

t-suzuki@ishizuchi-eye-clinic.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Suzuki

Organization

Ishizuchi Eye Clinic

Division name

Director

Zip code

7920811

Address

1-8-30 Shonaicho Niihama-city Ehime

TEL

0897333069

Homepage URL


Email

t-suzuki@ishizuchi-eye-clinic.jp


Sponsor or person

Institute

Ishizuchi Eye Clinic

Institute

Department

Personal name



Funding Source

Organization

Alcon Japan Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Riverside

Address

2-1Shitijo, chuou-ku, Sapporo

Tel

011-521-2321

Email

m.oota@riversideclinic.or.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 11 Month 14 Day

Last modified on

2020 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name