UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of Corneal crosslinking for keratoconic eyes
Title of the study (Brief title)	The examination of Corneal crosslinking for keratoconic eyes
Region	Japan

Condition
Condition	Keratoconus,Keratectasia,Peroxide corneal degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy and safety of corneal crosslinking using a new protocol (18mW/cm2,5minutes) with the KXL for progressing keratoconic eyes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of visual acuity,manifest refraction,keratometric value, and corneal topography
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	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Corneal crosslinking
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	14 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Age 14 years old or more 2.Thinnest corneal thickness is 400 um or more 3.Progression of keratoconus in recent 2 years by corneal topography/tomography and or manifest refraction.Progression of keratoctasia after corneal refractive surgery
Key exclusion criteria	1.Age less than 14 years old 2.Those who implanted artificial caridiac pacemaker or similar devices 3.pregnacy breast feeding 4.Occupation that is not allowed performing corneal wound healing, or nystagmus 5.Genearal diseases that can affect the corneal wound healig 6.Thinnest corneal thickness is less than 400 um 7.Ocular diseases,such as scar, herpetic infection, cornea stromal opacity,nallow angle, infectious corneal disordos with unknown causes.
Target sample size	100

Research contact person
Name of lead principal investigator	Kozue Kasai
Organization	The Jikei University School of Medicine
Division name	Department of Opthalmolgy
Address	3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL	03-3433-1111
Email	atago@skk-mail.jp

Public contact
Name of contact person	Kozue Kasai
Organization	The Jikei University School of Medicine
Division name	Department of Opthalmolgy
Address	3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL	03-3433-1111
Homepage URL
Email	atago@skk-mail.jp

Sponsor
Institute	Medical Corporation shinko-kai, Atago eye clinic
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)

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	2016 Year 07 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2016 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026950