UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Title of the study (Brief title)	Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	Conduct anterior capsulotomy using a new product called Zepto during cataract surgery, and compare it with forceps or cystotome on clinical and basic aspect.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A.Clinical Study Clinical use will only be applied to the patient who agreed and controlled study will not be conducted. Zepto will be used for anterior capsulotomy during cataract surgery only for the patients with consent. Clinical test items are visual acuity, intraocular pressure, wavefront aberration, refraction degree, corneal endothelium, flare meter, corneal thickness (anterior segment OCT), tilt of intraocular lens (IOL Master, anterior segment OCT), roundness of anterior capsulotomy incision and complete cover rate (wavefront aberration, slit lamp). Test will be done before and one day, one week, one month, three months, six months, and one year after the surgery. After that, same test will be done every year. B. Basic Study Basic test items are observation of tissues clinically obtained from anterior capsule or corpse eye provided by eye bank in the United States by optical microscope, transmission electron microscope or scanning electron microscope, and strength test using capsule from corpse eye.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
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	Device,equipment
Interventions/Control_1	ZEPTO
Interventions/Control_2	CCC
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	Patient who wish to have cataract surgery, who agree with the use of Zepto after explanation, who are able to be observed for 3 months after the surgery, and who fills the following adaptive criterions. 1)Over 20 years old 2)Visual function disorder due to cataract 3)Fully understands the explanation of this test
Key exclusion criteria	1)Congenital cataract 2)Medical history of corneal disease (corneal dystrophy, corneal endothelial disorder, etc.) 3)Pregnant or nursing woman
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuo Ichikawa
Organization	Chukyo Eye Clinic
Division name	Chukyo Eye Clinic
Address	12-23 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL	052-683-5001
Email	home@chukyomedical.co.jp

Public contact
Name of contact person	Kei Ichikawa
Organization	Japanese Red Cross Gifu Hospital
Division name	Department of Ophthalmology
Address	3-36 Iwakura-cho, Gifu-shi, Gifu
TEL	052-683-5001
Homepage URL
Email	home@chukyomedical.co.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yokohama Sky Eye Clinic Manabe Eye Center
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 03 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 13 Day
Anticipated trial start date	2017 Year 03 Month 13 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 13 Day
Last modified on	2017 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030457