UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of corneal crosslinking using KXL for keratoconic eyes
Title of the study (Brief title)	Corneal crosslinking using KXL
Region	Japan

Condition
Condition	Keratoconus
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 (ultraviolet irradiation; 18 mW/cm2 x 5 minutes) with the KXL(R)(Avedro, Inc) 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	Decrease of best corrected visual acuity, decrease of endothelial cell counts, and frequency of complications

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	Maneuver
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	Those who reveal all of following factors; 1. Keratoconus or keartectasia pattern by corneal topography/tomography 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 keratectasia after corneal refractive surgery. 4. Age 40 year-old or more.
Key exclusion criteria	Those who reveal one or more of following factors; 1. Thinnest corneal thickness is less than 400 um. 2. Corneal stromal opacity 3. Those who implanted artificial cardiac pacemaker or similar devices. 4. Ocular diseases, such as scar, herpetic infection, or nystagmus. 5. Infectious corneal disorders with unkonwn causes. 6. General diseases that can affect the corneal wound healing 7. Nallow angle, pregnancy, breast feeding 8. Occupation that is not allowed performing corneal refractive surgeries 9. Age less than 14 year-old
Target sample size	10

Research contact person
Name of lead principal investigator	Jun Shimazaki
Organization	Ichikawa General Hospital, Tokyo Dental College
Division name	Department of Ophthalmology
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	047-322-0151
Email	jun@eyebank.or.jp

Public contact
Name of contact person	Jun Shimazaki
Organization	Ichikawa General Hospital, Tokyo Dental College
Division name	Department of Ophthalmology
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	047-322-0151
Homepage URL
Email	jun@eyebank.or.jp

Sponsor
Institute	Department of Ophthalmology, Ichikawa General Hospital, Tokyo Dental College
Institute
Department

Funding Source
Organization	Tokyo Dental College
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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 08 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 31 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017109