UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015947
Receipt number R000018533
Scientific Title Comparison of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography with those using an existing measurement devices for cataract patients
Date of disclosure of the study information 2014/12/15
Last modified on 2017/06/20 18:08:42

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Basic information

Public title

Comparison of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography with those using an existing measurement devices for cataract patients

Acronym

Outcomes of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography

Scientific Title

Comparison of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography with those using an existing measurement devices for cataract patients

Scientific Title:Acronym

Outcomes of accuracy of intraocular lens power calculation and measurement time using a new integrated device consisting of the optical axial length measurement apparatus and a corneal topography

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the measurement time and accuracy of intraocular lens power calculation using Galilli 6 with those using conventional devices(IOL master and CASIA)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Difference in the measurement time
2) Difference in accuracy in intraocular lens power calculation

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who undergo phacoemulsification and aspiration with intraocularlens implantation
2)Patients with a monofocal intraocular lens
3)Patients with good locomotive function related to the measurement
4)Patinets who are able to and give consent to participation in this study.

Key exclusion criteria

1)Patients with a systemic or ocular disease, or a history of surgery that may influence visual function
2)Patients who are using drugs that may influence visual function
3)Decrease in cognitive function and locomotive disability that may affect the results of the study
4)Contact lens users who can't stop using contact lenses for definite term before measurements

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan

TEL

03-5363-3821

Email

fwic7788@mb.infoweb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan

TEL

03-5363-3821

Homepage URL


Email

fwic7788@mb.infoweb.ne.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 15 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

2013 Year 06 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 22 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

2014 Year 12 Month 15 Day

Last modified on

2017 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018533


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name