UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026522 |
|---|---|
| Receipt number | 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 13:51:43 |
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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
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
home@chukyomedical.co.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030457
