UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of safety and efficacy of back-flow hydrodissection
Acronym	Back-flow hydrodissection
Scientific Title	Evaluation of safety and efficacy of back-flow hydrodissection
Scientific Title:Acronym	Back-flow hydrodissection
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of back-flow hydrodissection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of cases which achieved rotatable lens nucleus at the time of surgery
Key secondary outcomes	Safety of back-flow hydrodissection

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Cataract surgery
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	40 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases eligible for standard cataract surgery
Key exclusion criteria	Cases with small pupil
Target sample size	270

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Hirota
Organization	Hirota Eye Clinic
Division name	Division of Ophthalmology
Zip code	745-0017
Address	1-25-1 Shinmachi, Shunan, Yamaguchi
TEL	0834-21-4877
Email	hiroeye@lion.ocn.ne.jp

Public contact
Name of contact person	1st name Tetsuro Middle name Last name Oshika
Organization	University of Tsukba
Division name	Department of Ophthalmology
Zip code	305-8575
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL	029-853-3148
Homepage URL
Email	oshika@eye.ac

Sponsor
Institute	Hirota Eye Clinic
Institute
Department

Funding Source
Organization	Hirota Eye Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirota Eye Clinic
Address	1-25-1 Shinmachi Shunan, Yamaguchi
Tel	0834-21-4877
Email	hiroeye@lion.ocn.ne.jp

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	2018 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	200
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	Completed
Date of protocol fixation	2018 Year 12 Month 19 Day
Date of IRB	2018 Year 12 Month 19 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry	2019 Year 05 Month 03 Day
Date trial data considered complete	2019 Year 05 Month 10 Day
Date analysis concluded	2019 Year 05 Month 16 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 19 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040241