UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019888
Receipt number R000022973
Scientific Title Effect of H2 gas for the phacoemulsification of cataract surgery
Date of disclosure of the study information 2016/11/24
Last modified on 2020/07/01 16:42:32

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Basic information

Public title

Effect of H2 gas for the phacoemulsification of cataract surgery

Acronym

Effect of H2 gas for the phacoemulsification of cataract surgery

Scientific Title

Effect of H2 gas for the phacoemulsification of cataract surgery

Scientific Title:Acronym

Effect of H2 gas for the phacoemulsification of cataract surgery

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

relief from corneal endothelial damage by the phacoemulsification

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Density of corneal endothelium

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

hydrogen

Interventions/Control_2

ocular irrigating solution

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

Cataract

Key exclusion criteria

No operation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Takahashi

Organization

Nippon Medical School

Division name

Ophthalmology

Zip code


Address

1-1-5 Sendagi,Bunkyo-ku,Tokyo

TEL

03-3822-2131

Email

tash@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomonaga Takase

Organization

Nippon Medical School Hospital

Division name

IRB

Zip code


Address

1-1-5 Sendagi,Bunkyo-ku,Tokyo

TEL

03-3822-2131

Homepage URL


Email

clinicaltrial@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School Ophthalmology

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

2016 Year 11 Month 24 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

Terminated

Date of protocol fixation

2015 Year 11 Month 15 Day

Date of IRB

2015 Year 10 Month 07 Day

Anticipated trial start date

2016 Year 03 Month 28 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Migrated to another database
jRCT number; jRCTs031180279


Management information

Registered date

2015 Year 11 Month 21 Day

Last modified on

2020 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022973


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name