UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Corneal Cross-linking on Endothelial Cell Morphology in the Peripheral Cornea
Title of the study (Brief title)	Effect of Corneal Cross-linking on Endothelial Cell Morphology in the Peripheral Cornea
Region	Japan

Condition
Condition	Progressive Keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of Corneal Cross-linking on Endothelial Cell Morphology in the Peripheral Cornea
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endothelial Cell Density, coefficient of variation and hexagonal cell in the peripheral cornea
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Keratoconic patients in whom the progression of the disease was recorded in the preceding 6 to 12 months, and who underwent standard corneal cross-linking treatment
Key exclusion criteria	Eyes with pellucid marginal degeneration, other corneal diseases, and previous ocular trauma or surgery
Target sample size	20

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University
Division name	School of Allied Health
Address	1-15-1, Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL	0427788464
Email	kamiya-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	Kitasato University
Division name	School of Allied Health
Address	1-15-1, Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL	0427788464
Homepage URL
Email	kamiya-tky@umin.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 02 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 06 Day
Anticipated trial start date	2018 Year 02 Month 06 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	Endothelial Cell Density, coefficient of variation and hexagonal cell in the peripheral cornea

Management information
Registered date	2018 Year 02 Month 06 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035561