UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024094
Receipt number R000027737
Scientific Title High-precision of intraocular lens power determination in cataract surgery
Date of disclosure of the study information 2016/09/20
Last modified on 2016/09/18 11:16:46

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Basic information

Public title

High-precision of intraocular lens power determination in cataract surgery

Acronym

High-precision of intraocular lens power determination in cataract surgery

Scientific Title

High-precision of intraocular lens power determination in cataract surgery

Scientific Title:Acronym

High-precision of intraocular lens power determination in cataract surgery

Region

Japan


Condition

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is aimed to improve the postoperative visual function by accurately determining the power of the intraocular lens to be inserted in cataract surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative visual ability and refraction

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

0 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

The patient who was planed to receive cataract surgery and could be examined before and after the operation.

Key exclusion criteria

The patient who had another disease expect for cataract.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuntaro Tsunehiro

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.

TEL

+81-42-778-8464

Email

tsune@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shuntaro Tsunehiro

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.

TEL

+81-42-778-8464

Homepage URL


Email

tsune@med.kitasato-u.ac.jp


Sponsor or person

Institute

University of Kitasato School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sanno Hospital

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

2016 Year 09 Month 20 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

Date of protocol fixation

2014 Year 04 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Unpublished


Management information

Registered date

2016 Year 09 Month 18 Day

Last modified on

2016 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027737


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name