UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Conventional Keratometry and Total Corneal Power in Normal Eyes.
Acronym	Comparison of Conventional Keratometry and Total Corneal Power in Normal Eyes.
Scientific Title	Comparison of Conventional Keratometry and Total Corneal Power in Normal Eyes.
Scientific Title:Acronym	Comparison of Conventional Keratometry and Total Corneal Power in Normal Eyes.
Region	Japan

Condition
Condition	normal eyes
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was aimed to compare conventional keratometry measured with an automated keratometer and total corneal power measured with corneal tomographer in normal eyes.
Basic objectives2	Others
Basic objectives -Others	relativity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison and relativity between the conventional keratometry and the total corneal power.
Key secondary outcomes

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	60 years-old >
Gender	Male and Female
Key inclusion criteria	normal eyes
Key exclusion criteria	Opthtalmic diseases, Previous history of ocular surgery or ocular trauma
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Rie Middle name Last name Hoshikawa
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	252-0373
Address	1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL	042-778-9671
Email	pink417dj@yahoo.co.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Hoshikawa
Organization	Kitasato University
Division name	School of Allied Health Sciences
Zip code	252-0373
Address	1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL	042-778-9671
Homepage URL
Email	pink417dj@yahoo.co.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Hospital
Address	1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
Tel	042-778-8273
Email	rinrib@med.kitasato-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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 04 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	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 04 Month 09 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate comparison and relativity between the conventional keratometry and the total corneal power.

Management information
Registered date	2019 Year 09 Month 04 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043233