UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032532 |
|---|---|
| Receipt number | R000030889 |
| Scientific Title | Cataract surgery using multifocal intraocular lens |
| Date of disclosure of the study information | 2018/05/09 |
| Last modified on | 2019/05/24 15:41:18 |
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Basic information
Public title
Cataract surgery using multifocal intraocular lens
Acronym
Cataract surgery using multifocal intraocular lens
Scientific Title
Cataract surgery using multifocal intraocular lens
Scientific Title:Acronym
Cataract surgery using multifocal intraocular lens
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the contribution for improving
quality of vision and life by cataract
surgery using multifocal intraocular lens
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of postoperative vision
Key secondary outcomes
Patinet's satisfaction, Percentage of wearing glasses.
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 |
Interventions/Control_1
cataract surgery using multifocal intraocular lens
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients having cataract and understandable at the future of multifocal intraocular lems
Key exclusion criteria
The patients expecting postoperatice poor visual acuity
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Suto |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Ophthalmology
Zip code
116-8567
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567,Japan
TEL
03-3810-1111
suto.chikako@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Suto |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Ophthalmology
Zip code
116-8567
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567,Japan
TEL
03-3810-1111
Homepage URL
suto.chikako@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Medical Center East
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
Tokyo Women's Medical University
Address
8-1Kawada-cho, Shinjuku-Ku, Tokyo
Tel
03-3353-8111
kobayakawa.naomi@twmu.ac.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
東京女子医科大学東医療センター眼科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 09 | 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
5
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
| 2017 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030889
