UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015626
Receipt number R000018159
Scientific Title Comparison daily activity level between pre- and post-cataract surgery
Date of disclosure of the study information 2014/11/08
Last modified on 2023/11/14 14:32:35

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Basic information

Public title

Comparison daily activity level between pre- and post-cataract surgery

Acronym

Daily activity level before and after cataract surgery

Scientific Title

Comparison daily activity level between pre- and post-cataract surgery

Scientific Title:Acronym

Daily activity level before and after cataract surgery

Region

Japan


Condition

Condition

Cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate daily activity level before and after cataract surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

METs

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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients scheduled for bilateral cataract surgery

Key exclusion criteria

Patients who have systemic and ocular disease except cataract and history of surgery, which affect visual function.
Patients who use drug which affect visual function.
Patients who have poor motor function.
Patients whose interval of scheduled date of bilateral cataract surgery is over one month.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kazuno
Middle name
Last name Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3821

Email

fwic7788@mb.infoweb.ne.jp


Public contact

Name of contact person

1st name Hidemasa
Middle name
Last name Torii

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3821

Homepage URL


Email

hidemasatorii@yahoo.co.jp


Sponsor or person

Institute

Department of Ophthalmology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

The institutional review board of Keio University School of Medicine

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-5363-3611

Email

med-rinri-jimu@adst.keio.ac.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

2014 Year 11 Month 08 Day


Related information

URL releasing protocol

None due to interruption/termination of research in the middle of the project.

Publication of results

Unpublished


Result

URL related to results and publications

None due to interruption/termination of research in the middle of the project.

Number of participants that the trial has enrolled

33

Results

Since there were no new participants in this study due to the new coronavirus outbreak, and moreover, many people are still refraining from outdoor activities, the continuation of this study was deemed to be no more feasible, and was discontinued and terminated.

Results date posted

2023 Year 11 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

None due to interruption/termination of research in the middle of the project.

Participant flow

None due to interruption/termination of research in the middle of the project.

Adverse events

None due to interruption/termination of research in the middle of the project.

Outcome measures

None due to interruption/termination of research in the middle of the project.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2014 Year 11 Month 08 Day

Date of IRB

2014 Year 09 Month 29 Day

Anticipated trial start date

2014 Year 11 Month 08 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To observe daily activity level before and after cataract surgery.


Management information

Registered date

2014 Year 11 Month 07 Day

Last modified on

2023 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018159


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name