UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031223
Receipt number R000035455
Scientific Title Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Date of disclosure of the study information 2018/03/01
Last modified on 2020/02/12 09:28:42

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Basic information

Public title

Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.

Acronym

Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.

Scientific Title

Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.

Scientific Title:Acronym

Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.

Region

Japan


Condition

Condition

high myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between posterior staphyloma and high myopia

Basic objectives2

Others

Basic objectives -Others

risk factor of posterior staphyloma

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

measure the refraction value, visual acuity, axial length and so on every six months

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Retrospective study: patients who have already developped posterior staphyloma
Prospective study: patients aged between 40 and 50 who have not developped posterior staphyloma in both eyes or have developped posterior staphylpma in one eye

Key exclusion criteria

other than those above

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Hieda

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

602-8566

Address

465 Kajii-cho,Kamigyo-ku,Kyoto city

TEL

075-251-5578

Email

msasaki@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Miho
Middle name
Last name Sasaki

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

602-8566

Address

465 Kajii-cho,Kamigyo-ku,Kyoto city

TEL

075-251-5578

Homepage URL


Email

msasaki@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society For The Promotion Of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural Universuty of Medicine

Address

465 Kajii-cho,Kamigyo-ku,Kyoto city

Tel

0752515578

Email

msasaki@koto.kpu-m.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

2018 Year 03 Month 01 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

Suspended

Date of protocol fixation

2017 Year 08 Month 31 Day

Date of IRB

2018 Year 03 Month 07 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective and retrospective study(Observational study)


Management information

Registered date

2018 Year 02 Month 09 Day

Last modified on

2020 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name