UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of the shape of anterior cornea based on the new corneal topography for ocular surface disease.
Acronym	The analysis of the shape of anterior cornea for ocular surface disease.
Scientific Title	The analysis of the shape of anterior cornea based on the new corneal topography for ocular surface disease.
Scientific Title:Acronym	The analysis of the shape of anterior cornea for ocular surface disease.
Region	Japan

Condition
Condition	Ocular surface disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the ability of the new corneal topography for diagnosing and grading values for ocular surface disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Several parameters derived from the shape of Meyer ring measured by topography with built-in software were evaluated and compared with the results of the other examination.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	RET-7000 Corneal topography was performed single time at the only day they 1st arrived. RET-7000 performed in less than one minute as non invasive, non contact imaging system.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	This study involved the patients who visited Kyoto Prefectural University of medicine between the day of approval and December 2019. All eyes were diagnosed as ocular surface disease.The patient who can agree with the consent form of this study was included.
Key exclusion criteria	The patient who judged as Inappropriate for this study by ophthalmologist were not included.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name itoi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-8566
Address	465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
TEL	0752515578
Email	mope@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Motohiro Middle name Last name itoi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-8566
Address	465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
TEL	075-251-5578
Homepage URL
Email	mope@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	IRB of Kyoto Prefectural University of Medicine
Address	465 Kajiicho, Kamigyo-ku, Kyoto 602-8065 JAPAN
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	2019 Year 12 Month 31 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
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	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
Date of IRB	2018 Year 03 Month 03 Day
Anticipated trial start date	2018 Year 12 Month 15 Day
Last follow-up date	2020 Year 08 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 08 Month 10 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 24 Day
Last modified on	2020 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034574