UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006853 |
|---|---|
| Receipt number | R000008102 |
| Scientific Title | Comparison between multi and single focal intraocular lens implantation |
| Date of disclosure of the study information | 2011/12/07 |
| Last modified on | 2014/06/05 21:16:14 |
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Basic information
Public title
Comparison between multi and single focal intraocular lens implantation
Acronym
Clinical results of multi focal intraocular lens implantation
Scientific Title
Comparison between multi and single focal intraocular lens implantation
Scientific Title:Acronym
Clinical results of multi focal intraocular lens implantation
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical result of multifocal intraocular lens implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rates of eyeglasses wear
Key secondary outcomes
The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
multifocal intraocular lens implantation
Interventions/Control_2
singlefocal intraocular lens implantation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing implantation with TECIS multifocal IOL and TECNIS
Key exclusion criteria
Patients found to have other ocular diseases or a postoperative spherical error target other than emmetropia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tabuchi |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
Address
68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL
0792728555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tabuchi |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
Address
68-1 Waku Aboshi-ku Himeji HYOGO,JAPAN
TEL
0792728555
Homepage URL
H.Tabuchi@tuskazaki-eye.net
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Saneikai Tsukazaki Hospital
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
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
ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 07 | Day |
Last modified on
| 2014 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
