UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Trial of corneal crosslinking for keratoconus and keratoectasia
Acronym	Clinical Trial of corneal crosslinking for keratoconus and keratoectasia
Scientific Title	Clinical Trial of corneal crosslinking for keratoconus and keratoectasia
Scientific Title:Acronym	Clinical Trial of corneal crosslinking for keratoconus and keratoectasia
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of corneal crosslinking for keratoconus and keratoectasia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Uncorrected and best corrected visual acuity, maximum corneal refractive power in corneal topography
Key secondary outcomes	corneal thickness measured by anterior segment OCT

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	corneal crosslinking with removal of corneal epithelium
Interventions/Control_2	corneal crosslinking without removal of corneal epithlium
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	14 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Those whose age at obtaining informed consent meet following criteria Keratoconus: 14 years old and more Keratoectasia: 20 years old and more 2) Those whose diagnosis by corneal topography is keratoconus, keratoconus suspect or keratoectasia 3) The thinnest corneal thickness is over 400 micron meter. In the case that corneal thickness is less than 400 micron meter, it is necessary of more than 400 micro meter of corneal thickness during surgery after adding hypotonic riboflavin solution. In case without removal of corneal epithelium, the criteria is more than 380 micro meter of corneal thickness. 4) Progressive keratoconus or keratoectasia meeting any of the following criteria; -the maximum corneal refractive power (Kmax) increases of more than 1 diopter -manifest astigmatism increases of more than 1 diopter -manifest spherical equivalent increases more than 1 diopter -base curve of hard contact lenses decreases of more than 0.1mm 5) In case of keratoconus, no history of acute hydropes 6) In case of keratoectasia, those who have a history of refractive surgery such as LASIK 7) Patients whose voluntary consent document was obtained after receiving enough explanation about this study 8) Outpatient
Key exclusion criteria	1)Those undergoing drug therapy for such as glaucoma, more than moderate dry eye or allergy 2)those with ocular disease such as uveitis 3)those with systemic disease that can affect wound healing, such as diabetes 4)Those without obvious progression of the disease for a year before sugery 5)Those with corneal melting disase 6)Those without lens 7)Those with intraocular lens which have no protective function against ultraviolet 8)Woman who are or might be pregnant 9)Lactating woman 10) Those who received other investigational clinical trials within 3 months before the beginning of this study 11) Patients who are judged to be unsuitable as a subject by investigator
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tomohiko Usui
Organization	the University of Tokyo Hospital
Division name	Department of Ophthalmology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	tomohiko-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Tomohiko Usui
Organization	the University of Tokyo Hospital
Division name	Department of Ophthalmology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	tomohiko-tky@umin.ac.jp

Sponsor
Institute	the University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Non
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
Address
Tel
Email

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	2012 Year 11 Month 21 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	Completed
Date of protocol fixation	2012 Year 06 Month 27 Day
Date of IRB	2011 Year 10 Month 20 Day
Anticipated trial start date	2012 Year 06 Month 27 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 11 Month 21 Day
Last modified on	2019 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011016