UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037273
Receipt number R000042497
Scientific Title Keratoconus Screening among Myopic Children
Date of disclosure of the study information 2019/07/04
Last modified on 2019/07/04 22:22:58

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Basic information

Public title

Keratoconus Screening among Myopic Children

Acronym

Keratoconus Screening among Myopic Children

Scientific Title

Keratoconus Screening among Myopic Children

Scientific Title:Acronym

Keratoconus Screening among Myopic Children

Region

North America


Condition

Condition

myopic children

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

screening of keratoconus

Basic objectives2

Others

Basic objectives -Others

screening of keratoconus

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

kc in 9.2%

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

6 years-old <=

Age-upper limit

14 years-old >=

Gender

Male and Female

Key inclusion criteria

high myopia

Key exclusion criteria

previous ocular surgery or trauma

Target sample size

174


Research contact person

Name of lead principal investigator

1st name ismail
Middle name
Last name omar

Organization

minia university

Division name

ophthalmology dept

Zip code

61111

Address

minia university hospital

TEL

+201002554116

Email

ismail.omar@mu.edu.eg


Public contact

Name of contact person

1st name ismail
Middle name
Last name omar

Organization

minia university

Division name

Ophthalmology

Zip code

61111

Address

minia university hospital

TEL

+201002554116

Homepage URL


Email

ismail.omar@mu.edu.eg


Sponsor or person

Institute

faulty of medicine
ophthalmology dept

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

minia university

Address

minia

Tel

+201002554116

Email

ismail.omar@mu.edu.eg


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

2019 Year 07 Month 04 Day


Related information

URL releasing protocol

unpublished

Publication of results

Unpublished


Result

URL related to results and publications

unpublished

Number of participants that the trial has enrolled

174

Results

9.2% had keratoconus.

Results date posted

2019 Year 07 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Unpublished

Participant flow

Unpublished

Adverse events

Unpublished

Outcome measures

Unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB

2015 Year 04 Month 01 Day

Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date

2018 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

corneal topography and elevation of corneas of the examined high myopia children


Management information

Registered date

2019 Year 07 Month 04 Day

Last modified on

2019 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name