UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Acronym	Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Scientific Title	Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Scientific Title:Acronym	Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Region	Japan

Condition
Condition	Keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Customized CXL for advanced keratoconus was performed in 57 cases, 80 eyes by Cone shape (24 nipple type, 28 oval type, globus type 28 eyes), and changes in visual acuity, refraction, corneal refractive power, and satisfaction (VAS) in each group were examined before and after 3 months after surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in visual acuity, refraction, corneal refractive power, and satisfaction (VAS) in each group 3 months before and after surgery
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	18 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Progression keratoconus
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shouji Middle name Last name Nobuyuki
Organization	Kitasato Univ.
Division name	Ophthalmology
Zip code	2520374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL	0427788111
Email	masatakahashi-ktz@umin.ac.jp

Public contact
Name of contact person	1st name masahide Middle name Last name takahasi
Organization	Kitasato Univ.
Division name	Ophthalmology
Zip code	2520374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL	0427788111
Homepage URL
Email	masatakahashi-ktz@umin.ac.jp

Sponsor
Institute	Kitasato Univ.
Institute
Department

Funding Source
Organization	Kitasato Univ.
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 School of Medicine
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel	0427788111
Email	masatakahashi-ktz@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	2020 Year 10 Month 15 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
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	Preinitiation
Date of protocol fixation	2020 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 07 Day
Last follow-up date	2020 Year 10 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 05 Month 07 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046010