UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027326 |
|---|---|
| Receipt number | R000031309 |
| Scientific Title | Long term outcome of diffractive multifocal intraocular lens implantation with long axial lengths |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2024/05/17 17:10:22 |
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Basic information
Public title
Long term outcome of diffractive multifocal intraocular lens implantation with long axial lengths
Acronym
Long term outcome of multifocal IOL with long axial lengths
Scientific Title
Long term outcome of diffractive multifocal intraocular lens implantation with long axial lengths
Scientific Title:Acronym
Long term outcome of multifocal IOL with long axial lengths
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficiency of diffractive multifocal intraocular lens with long axial lengths
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
subjective refraction, corneal astigmatism, glare, halos, 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases without ocular disease
cases without history of keratorefractive surgery
Key exclusion criteria
cases with ocular diseases which affect visual acuity
amblyopia
cases with history of ocular surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Bissenn Miyajima Hiroko |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-5275-1856
bissen@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Ota |
Organization
Tokyo Dental College Suidobashi Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-5275-1856
Homepage URL
yota@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College Suidobashi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
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 | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031309
