UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046047
Receipt number R000052558
Scientific Title Comparison of Predictability of Refractive Lens Exchange in Middle-aged Patients.
Date of disclosure of the study information 2021/11/30
Last modified on 2021/11/11 18:10:05

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Basic information

Public title

Comparison of Predictability of Refractive Lens Exchange in Middle-aged Patients.

Acronym

Comparison of Predictability of Refractive Lens Exchange in Middle-aged Patients.

Scientific Title

Comparison of Predictability of Refractive Lens Exchange in Middle-aged Patients.

Scientific Title:Acronym

Comparison of Predictability of Refractive Lens Exchange in Middle-aged Patients.

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of Predictability post cataract surgery

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Predictability post cataract surgery

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Catract patients

Key exclusion criteria

eye disease without cataract

Target sample size

24


Research contact person

Name of lead principal investigator

1st name hayakawa
Middle name
Last name hideki

Organization

kitasato university of hospital

Division name

opthalmology

Zip code

2520329

Address

1-15-1 kitasato, minami ward, sagamihara sity, kanagawa

TEL

0427788464

Email

m09088w@st.kitasato-u.ac.jp


Public contact

Name of contact person

1st name hayakawa
Middle name
Last name hideki

Organization

kitasato university of hospital

Division name

opthalmology

Zip code

2520329

Address

1-15-1 kitasato, minami ward, sagamihara sity, kanagawa

TEL

0427788464

Homepage URL


Email

m09088w@st.kitasato-u.ac.jp


Sponsor or person

Institute

kitasato university of hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

kitasato university of hospital

Address

1-15-1 kitasato, minami ward, sagamihara sity, kanagawa

Tel

042-778-8464

Email

rinrib@med.kitasato-u.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

2021 Year 11 Month 30 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

2021 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2021 Year 11 Month 30 Day

Last follow-up date

2023 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 11 Month 11 Day

Last modified on

2021 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052558


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name