UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000031653