UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035317
Receipt number R000040241
Scientific Title Evaluation of safety and efficacy of back-flow hydrodissection
Date of disclosure of the study information 2018/12/19
Last modified on 2019/12/19 09:39:16

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Basic information

Public title

Evaluation of safety and efficacy of back-flow hydrodissection

Acronym

Back-flow hydrodissection

Scientific Title

Evaluation of safety and efficacy of back-flow hydrodissection

Scientific Title:Acronym

Back-flow hydrodissection

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of back-flow hydrodissection

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ratio of cases which achieved rotatable lens nucleus at the time of surgery

Key secondary outcomes

Safety of back-flow hydrodissection


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 Maneuver

Interventions/Control_1

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

40 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases eligible for standard cataract surgery

Key exclusion criteria

Cases with small pupil

Target sample size

270


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Hirota

Organization

Hirota Eye Clinic

Division name

Division of Ophthalmology

Zip code

745-0017

Address

1-25-1 Shinmachi, Shunan, Yamaguchi

TEL

0834-21-4877

Email

hiroeye@lion.ocn.ne.jp


Public contact

Name of contact person

1st name Tetsuro
Middle name
Last name Oshika

Organization

University of Tsukba

Division name

Department of Ophthalmology

Zip code

305-8575

Address

1-1-1 Tennoudai, Tsukuba, Ibaraki

TEL

029-853-3148

Homepage URL


Email

oshika@eye.ac


Sponsor or person

Institute

Hirota Eye Clinic

Institute

Department

Personal name



Funding Source

Organization

Hirota Eye Clinic

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

Hirota Eye Clinic

Address

1-25-1 Shinmachi Shunan, Yamaguchi

Tel

0834-21-4877

Email

hiroeye@lion.ocn.ne.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 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

200

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

2018 Year 12 Month 19 Day

Date of IRB

2018 Year 12 Month 19 Day

Anticipated trial start date

2018 Year 12 Month 19 Day

Last follow-up date

2019 Year 04 Month 30 Day

Date of closure to data entry

2019 Year 05 Month 03 Day

Date trial data considered complete

2019 Year 05 Month 10 Day

Date analysis concluded

2019 Year 05 Month 16 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 19 Day

Last modified on

2019 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name