UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of femtosecond-assisted keratoplasty
Title of the study (Brief title)	Femtosecond-assisted keratoplasty
Region	Japan

Condition
Condition	Corneal diseases, such as corneal opacity, keratoconus, bullous keratoplasty, etc.
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of femtosecond laser-assisted keratoplasty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity, intraocular pressure, corneal tomography, corneal endothelial cell density, complications.
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	Device,equipment
Interventions/Control_1	Femtosecond laser-assisted keratoplasty
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Those who have corneal diseases that are indicated for keratoplasty, such as corneal opacity, keratoconus, or bullous keratopathy. 2. Age 20 year-old, or more. 3. No sign of other ocular diseases, such as active uveitis, glaucoma, etc. 4. No history of general diseases that could affect the wound healing, such as diabetes mellitus. 5. Those who can provide informed consent.
Key exclusion criteria	1. Those who have dense corneal opacity that interfere laser incision. 2. Age 19 year-old or less. 3. Signs of other ocular diseases, such as active uveitis. glaucoma, etc. 4. History of general diseases that could affect the would healing, such as diabetes mellitus. 5. Those who have no capacity to provide informed consent.
Target sample size	30

Research contact person
Name of lead principal investigator	Naoko Kato
Organization	Saitama Medical University
Division name	Department of Ophthalmology
Address	Morohongo 38, Iruma, Saitama
TEL	049-276-1250
Email	naokato@saitama-med.ac.jp

Public contact
Name of contact person	Naoko Kato
Organization	Saitama Medical University
Division name	Department of Ophthalmology
Address	Morohongo 38, Iruma, Saitama
TEL	049-276-1250
Homepage URL
Email	naokato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
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 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 03 Day
Anticipated trial start date	2017 Year 06 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 23 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030630