UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015239
Receipt number R000017716
Scientific Title Morphological analysis of the eye elongation
Date of disclosure of the study information 2014/10/01
Last modified on 2020/04/06 15:52:52

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Basic information

Public title

Morphological analysis of the eye elongation

Acronym

Morphological analysis of the eye elongation

Scientific Title

Morphological analysis of the eye elongation

Scientific Title:Acronym

Morphological analysis of the eye elongation

Region

Japan


Condition

Condition

normal eyes and myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the morphological change of the eye elongation in young healthy eyes using optical coherence tomography.

Basic objectives2

Others

Basic objectives -Others

Observational study

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship between axial length elongation and morphological change of the eye (tessellation, optic disc tilt and retinal nerve fiber trajectory)

Key secondary outcomes

Relationship between axial length elongation, life activities and body height


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

8 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Agreement of participants and parents
Normal eyes

Key exclusion criteria

Eye disease
Systemic diseases affecting eyes
No reliable examinaiton

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Takehiro
Middle name
Last name Yamashita

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Ophthalmology

Zip code

8908544

Address

8-35-1 Sakuragaoka, Kagoshima JAPAN

TEL

099-275-5402

Email

take1@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Takehiro
Middle name
Last name Yamashita

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Ophthalmology

Zip code

890-8544

Address

8-35-1 Sakuragaoka, Kagoshima JAPAN

TEL

099-275-5402

Homepage URL


Email

take1@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Kagoshima University Graduate School of Medical and Dental Sciences

Address

8-35-1 Sakuragaoka, Kagoshima JAPAN

Tel

099-275-5111

Email

take1@m.kufm.kagoshima-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

鹿児島大学眼科(鹿児島県)、鹿児島大学付属小学校・中学校(鹿児島県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 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

Open public recruiting

Date of protocol fixation

2014 Year 01 Month 20 Day

Date of IRB

2014 Year 02 Month 20 Day

Anticipated trial start date

2014 Year 10 Month 27 Day

Last follow-up date

2024 Year 03 Month 15 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2030 Year 03 Month 31 Day


Other

Other related information

Observational period
10 years from the third-grade
3 years from the seventh-grade

Methods
Axial length, optical coherence tomography, fundus photograph, body height, body weight, questionnaire


Management information

Registered date

2014 Year 09 Month 24 Day

Last modified on

2020 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017716


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name