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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020258
Receipt No. R000023390
Scientific Title hydrodissection with one-hole sleeve during cataract surgery
Date of disclosure of the study information 2016/01/15
Last modified on 2015/12/17

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Basic information
Public title hydrodissection with one-hole sleeve during cataract surgery
Acronym one-hole sleeve hydro-surgery
Scientific Title hydrodissection with one-hole sleeve during cataract surgery
Scientific Title:Acronym one-hole sleeve hydro-surgery
Region
Japan

Condition
Condition Patients with cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using one-hole sleeve, we will evaluate the efficacy of hydrodissection effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the duration time of cortical cleaving hydrodissection, residual cortical area after phacoemulsification, the duration time of the cortical removing
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 cataract surgery with one-hole sleeve
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 patients with cataract
Key exclusion criteria none
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichiro Masuda
Organization Jikei Katsushika Medical Center
Division name Ophthalmology
Zip code
Address 6-41-2 Aoto Katsushika Tokyo
TEL 0336031111
Email massuuu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Masuda
Organization Jikei Katsushika Medical Center
Division name Ophthalmology
Zip code
Address 6-41-2 Aoto Katsushika Tokyo
TEL 03-3603-2111
Homepage URL
Email massuuu@gmail.com

Sponsor
Institute Jikei School of Medicine
Institute
Department

Funding Source
Organization Ophthalmology, Jikei University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 01 Month 15 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 15 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
2015 Year 12 Month 17 Day
Last modified on
2015 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023390

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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