UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020259
Receipt number R000023391
Scientific Title the evaluation of cataract surgery using dull tip
Date of disclosure of the study information 2016/01/15
Last modified on 2016/01/20 16:12:07

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Basic information

Public title

the evaluation of cataract surgery using dull tip

Acronym

cataract surgery with Dewey tip

Scientific Title

the evaluation of cataract surgery using dull tip

Scientific Title:Acronym

cataract surgery with Dewey tip

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Using dull tip during phacoemulsification, we evaluate the efficacy of lens cortical removal.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time of lens remova

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We utilize the Dewey tip one time during cataract surgery

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


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients with cataract

Key exclusion criteria

none

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichiro Masuda

Organization

Jikei Katsushika Medical Center

Division name

Ophthalmology

Zip code


Address

6-41-2 Aoto Katsushika Tokyo

TEL

03-3603-2111

Email

massuuu@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoichiro Masuda

Organization

Jikei Katsushika Medical Center

Division name

Ophthalmology

Zip code


Address

6-41-2 Aoto Katsushika Tokyo

TEL

03-3603-2111

Homepage URL


Email

massuuu@gmail.com


Sponsor or person

Institute

Jikei University, Shool of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ophthalmology, Jikei University, school of Medicine

Organization

Division

Category of Funding Organization

Other

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

2016 Year 01 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

Preinitiation

Date of protocol fixation

2015 Year 12 Month 17 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 17 Day

Last modified on

2016 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023391


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name