UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011112
Receipt number R000013016
Scientific Title Tear osmolality before and after cataract surgery
Date of disclosure of the study information 2013/07/04
Last modified on 2024/01/11 17:22:13

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Basic information

Public title

Tear osmolality before and after cataract surgery

Acronym

Tear osmolality and cataract surgery

Scientific Title

Tear osmolality before and after cataract surgery

Scientific Title:Acronym

Tear osmolality and cataract surgery

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Tear osmolality before and after cataract surgery

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Tear osmolality

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Tear osmolality

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

1) Patients aged 20 and over (sex unquestioned)
2) Patients received cataract surgery
3) Patients who provided written informed consent for participating in this study.

Key exclusion criteria

1) Patients who are considered to be inapproriate by the investigators.
2) Patients with drug allergy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name TSUTOMU
Middle name
Last name IGARASHI

Organization

Nippon Medical School

Division name

Ophthalmology

Zip code

1138602

Address

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

TEL

03-3822-2131

Email

tutomu@nms.ac.jp


Public contact

Name of contact person

1st name TOMONAGA
Middle name
Last name Takase

Organization

Nippon Medical School

Division name

Ophthalmology

Zip code

1138602

Address

1-1-5 Sendagi, Bunkyoku, 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

MHLW

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

Nippon Medical School Hospital

Address

1-1-5, Sendagi, Bunkyoku, Tokyo

Tel

03-3822-2131

Email

clinicaltrial@nms.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

2013 Year 07 Month 04 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jnms/88/3/88_JNMS.2021_88-405/_pdf/-char/en

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jnms/88/3/88_JNMS.2021_88-405/_pdf/-char/en

Number of participants that the trial has enrolled

39

Results

Results

Results date posted

2024 Year 01 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

39 patients (19 male, 20 female patients)

Participant flow

outpatient

Adverse events

nothing

Outcome measures

Schirmer test, BUT, Staining score, Tosm, corneal sensitivity

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 05 Month 17 Day

Date of IRB

2013 Year 05 Month 17 Day

Anticipated trial start date

2013 Year 07 Month 04 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 04 Day

Last modified on

2024 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013016


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name