UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018390
Receipt number R000021296
Scientific Title Evaluation of refractive correction for perimetric test in eye with multiforcal lens.
Date of disclosure of the study information 2015/07/23
Last modified on 2016/02/23 09:40:57

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Basic information

Public title

Evaluation of refractive correction for perimetric test in eye with multiforcal lens.

Acronym

Refractive correction for perimetric test in eye with multiforcal lens.

Scientific Title

Evaluation of refractive correction for perimetric test in eye with multiforcal lens.

Scientific Title:Acronym

Refractive correction for perimetric test in eye with multiforcal lens.

Region

Japan


Condition

Condition

healthy participants

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the refractive correction for perimetric test in eye with multiforcal contact lens.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mean sensitivity, area-wise mean sensitivity, point-wise sensitivity, mean deviation, visual field index, and pattern standard deviation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

wearing the bifocal contact lens

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

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

refractive error +3.00 to -6.00 D,
astigmatic power is less than 1.50 D,
Intraocular pressure is less than 21mmHg,
visual acuity is more than 1.0.

Key exclusion criteria

refractive error is higher than +3.00 and -6.00 D,
astigmatic power is more than 1.50 D,
Intraocular pressure is more than 22mmHg,
visual acuity is less than 0.9

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Shoji

Organization

School of Allied health sciences, KITASATO University

Division name

Orhoptics and Visual Science

Zip code


Address

1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan

TEL

042-778-9671

Email

nshoji@ahs.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Hirasawa

Organization

School of Allied health sciences, KITASATO University

Division name

Orhoptics and Visual Science

Zip code


Address

1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan

TEL

042-778-9671

Homepage URL


Email

hirasawa@kitasato-u.ac.jp


Sponsor or person

Institute

School of Allied health sciences, KITASATO University

Institute

Department

Personal name



Funding Source

Organization

Allied health sciences, KITASATO University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 07 Month 23 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

Completed

Date of protocol fixation

2015 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 29 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 12 Month 05 Day


Other

Other related information

Method of refractive correction


Management information

Registered date

2015 Year 07 Month 23 Day

Last modified on

2016 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021296


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name