UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of corneal crosslinking and hypertonic NaCl solution as a treatment for bullous keratopathy
Title of the study (Brief title)	Corneal crosslinking and hypertonic NaCl solution for bullous keratopathy
Region	Japan

Condition
Condition	Bulllous keratopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of corneal cross linking as a treatment for bullous keratopathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cornea thickness, subjective scores
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Medicine Maneuver
Interventions/Control_1	Corneal crosslinking
Interventions/Control_2	hypertonic saline instillation
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	# Corneal endothelial dysfunction # Decreased visual acuity and/or other subjective symptoms due to corneal edema.
Key exclusion criteria	# Other ocular surface diseases # Corneal infections # Severe dry eye # General diseases affecting wound healing on the ocular surface # In pregnancy or breast feeding
Target sample size	60

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

Public contact
Name of contact person	Naoko Kato
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Ophthalmology
Address	Sugano 5-11-13, Ichikawa, Chiba, Japan
TEL	047-322-0151
Homepage URL
Email	naokato@bc.iij4u.or.jp

Sponsor
Institute	Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization	Tokyo Dental College Ichikawa General Hospital
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	2017 Year 09 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 09 Day
Anticipated trial start date	2015 Year 04 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

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

Management information
Registered date	2017 Year 09 Month 26 Day
Last modified on	2018 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033498