UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026217 |
|---|---|
| Receipt number | R000030013 |
| Scientific Title | Prospective observational study on cataract surgery with multifocal intraocular lens implantation |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/01/16 16:08:39 |
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Basic information
Public title
Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Acronym
Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Scientific Title
Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Scientific Title:Acronym
Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate surgical results of multifocal intraocular lens implantation and patient's satisfaction in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corrected Visual acuity (Distance,near)
Uncorrected Visual acuity (Distance,near)
Key secondary outcomes
usage of spectacles,questionnaire,refraction,contrast sensitivity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who undergo cataract surgery with multifocal intraocular lens implantation at the institute registered to the registry system of advanced medical treatment( cataract surgery with multifocal intraocular lens implantation) that is administrated by the Japanese society of cataract and refractive surgery.
Key exclusion criteria
Patients who don't give their consent to this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Bissen-Miyajima |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of ophthalmology
Zip code
Address
2-9-18, Misakicho, Chiyoda-ku, Tokyo, Japan
TEL
03-5275-1856
bissen@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamanishi |
Organization
Japanese Society of Cataract and Refractive Surgery(JSCRS) questionnaire survey working group
Division name
Secretariat, Japanese Society of Cataract and Refractive Surgery(JSCRS)
Zip code
Address
3-2-16, Misakicho, Chiyoda-ku, Tokyo Japan
TEL
03-5226-7750
Homepage URL
jscrs@jscrs.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Keio 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
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
慶應委義塾大学病院ほか、日本屈折矯正手術学会より日本白内障屈折矯正手術学会の先進医療（多焦点眼内レンズを用いた水晶体再建術）登録システムに登録された施設
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030013
