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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026522
Receipt No. R000030457
Scientific Title Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Date of disclosure of the study information 2017/03/13
Last modified on 2017/08/29

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Basic information
Public title Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Acronym Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Scientific Title Basic and clinical evaluation of anterior capsulotomy using Zepto during cataract surgery
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Ichikawa
Organization Chukyo Eye Clinic
Division name Chukyo Eye Clinic
Zip code
Address 12-23 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL 052-683-5001
Email home@chukyomedical.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Ichikawa
Organization Japanese Red Cross Gifu Hospital
Division name Department of Ophthalmology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 13 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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