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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027626
Receipt No. 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

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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
Institute Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department

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
URL(English) https://upload.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


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