UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027626
Receipt number R000031653
Scientific Title A prospective study in the visual quality of pterygium surgery
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/04 23:06:51

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Basic information

Public title

A prospective study in the visual quality of pterygium surgery

Acronym

The effect on the the visual quality of the pterygium surgery

Scientific Title

A prospective study in the visual quality of pterygium surgery

Scientific Title:Acronym

The effect on the the visual quality of the pterygium surgery

Region

Japan


Condition

Condition

Pterygium

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is the analyzing the high order aberrations (HOAs), spherical aberrations, and Coma abberations of anterior, posterior, and total cornea before and after pterigium surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

logMAR,astigmatism, high-order aberrations(HOAs), spherical aberrations, coma aberrations, VFQ-25

Key secondary outcomes

VAS score


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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients of pterygium, who agree with this study

Key exclusion criteria

patients who dont agree with this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name TAKAHIKO
Middle name
Last name HAYASHI

Organization

Yokohama Minami Kyosai Hospital

Division name

Department of Ophthalmology

Zip code

2360037

Address

1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Japan

TEL

81457872101

Email

htakahiko-aikou@umin.ac.jp


Public contact

Name of contact person

1st name Takahiko
Middle name
Last name Hayashi

Organization

Yokohama Minami Kyosai Hospital

Division name

Department of Ophthalmology

Zip code

2360037

Address

Kanazawa-ku

TEL

+817038502167

Homepage URL


Email

takamed@gmail.com


Sponsor or person

Institute

Department of Ophthalmology, Yokohama Minami Kyosai Hospital

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

Yokohama Minami Kyosai Hospital

Address

1-21-1, Mutsuura-Higashi

Tel

+81457872101

Email

htakahiko-aikou@umin.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

2017 Year 07 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

50

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

the lack of statistic method

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

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2017 Year 06 Month 01 Day

Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 09 Month 30 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information

a prospective observational study


Management information

Registered date

2017 Year 06 Month 03 Day

Last modified on

2019 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031653


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name