UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035317 |
|---|---|
| Receipt number | R000040241 |
| Scientific Title | Evaluation of safety and efficacy of back-flow hydrodissection |
| Date of disclosure of the study information | 2018/12/19 |
| Last modified on | 2019/12/19 09:39:16 |
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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
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
oshika@eye.ac
Sponsor or person
Institute
Hirota Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040241
