UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of corneal crosslinking in progressive keratoconus
Acronym	Evaluation of corneal crosslinking
Scientific Title	Evaluation of corneal crosslinking in progressive keratoconus
Scientific Title:Acronym	Evaluation of corneal crosslinking
Region	Japan

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

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

Assessment
Primary outcomes	visual acuity, manifest visual acuity, corneal thickness, corneal higher order aberrations
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 One of the above conditions was found within 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 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	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kojima
Organization	Nagoya Eye Clinic
Division name	Ophthalmology
Zip code
Address	3F Meitetsu Kanayama Build., 25-1 Namiyose-cho, Atsuta-ku, Nagoya, Japan
TEL	0120-758-049
Email	kojima@chukyogroup.jp

Public contact
Name of contact person	1st name Middle name Last name Junko Sawada
Organization	Nagoya Eye Clinic
Division name	Ethics committee
Zip code
Address	3F Meitetsu Kanayama Build., 25-1 Namiyose-cho, Atsuta-ku, Nagoya, Japan
TEL	0120-758-049
Homepage URL
Email	nic-irb@lasik.jp

Sponsor
Institute	Nagoya Eye Clinic
Institute
Department

Funding Source
Organization	Nagoya Eye Clinic
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	名古屋アイクリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 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	2011 Year 05 Month 28 Day
Date of IRB	2011 Year 05 Month 15 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2018 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	2016 Year 11 Month 27 Day
Last modified on	2019 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028778