UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Corneal Crosslinking for keratoconus/keratectasia
Title of the study (Brief title)	Corneal Crosslinking for keratoconus
Region	Japan

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

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

Assessment
Primary outcomes	visual acuity, manifest refraction, keratometric readings, corneal thickness
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	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	1. Increase in Steepest K-value more than 1.0D 2. Increase in manifest cylinder more than 1.0D 3. Increase in manifest spherical equivalent more than 1.0D 4. Decrease of base curve of the back surface of best-fitted hard contact lens more than 1.0D One of the above conditions was shown within recent 24 months and the thinnest corneal thickness is 400 um or more.
Key exclusion criteria	The corneal thickness is less than 400 um Those who is implanted cardiac pacemaker, or other medical devices Non of the conditions below are observed; 1 Increase in Steepest K-value more than 1.0D 2 Increase in manifest cylinder more than 1.0D 3 Increase in manifest spherical equivalent more than 1.0D 4 Decrease of base curve of the back surface of best-fitted hard contact lens more than 1.0D Those who have ocular disorders, such as infections, scars, ocular herpes, nystagmus etc. those who have general diseases that can affect the corneal wound healing Narrow angle Those who is in pregnancy or breast-feeding Occupations that are not allowed to undergo refractive surgeries Age less than 14 year-old
Target sample size	30

Research contact person
Name of lead principal investigator	Tetsuya Kawakita
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	keio.eye.research.sec@gmail.com

Public contact
Name of contact person	Naoko Kato
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	nkato@ndmc.ac.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
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 04 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 05 Month 25 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 04 Month 17 Day
Last modified on	2017 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016041