UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029442
Receipt No. R000033640
Scientific Title Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto)
Date of disclosure of the study information 2017/10/05
Last modified on 2017/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto)
Acronym Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Scientific Title Comparison of anterior capsulotomy's postoperative long-term outcome by manual (anterior chamber forceps) and mechanical (Zepto)
Scientific Title:Acronym Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Region
Japan

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

Objectives
Narrative objectives1 Comparison of anterior capsulotomy's postoperative long-term outcome by manual and Zepto
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of anterior clouding and secondary cataract probability by manual using anterior chamber forceps and mechanical using Zepto.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Maneuver
Interventions/Control_1 Mechanical surgery by using Zepto for anterior capsulotomy during cataract surgery
Interventions/Control_2 Manual surgery by using anterior chamber forceps for anterior capsulotomy during cataract surgery
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 20 years old or older.
Patient with declined eye sight due to cataract.
Patient wish to have cataract surgery on both eyes.
Diameter of the pupil must be 7.00mm or larger when dilated.
Anterior chamber depth must be 2.5mm or deeper.
Patient should comprehend and agree with the explanation from the doctor.
Key exclusion criteria Congenital cataract
Patient with ocular disease other than cataract.
Patient with systemic disease such as diabetes or Marfan syndrome that may affect capsule.
Patient with eye disorder and systemic disease such as hypertension that does not affect capsule.
Pregnant or nursing woman.
Target sample size 50

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 10 Month 05 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 10 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 05 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 10 Month 05 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.