UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020637 |
|---|---|
| Receipt number | R000023742 |
| Scientific Title | Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation. |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2020/07/02 13:54:51 |
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Basic information
Public title
Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Acronym
Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Scientific Title
Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Scientific Title:Acronym
Functional visual acuity in eyes with monofocal and multifocal intraocular lens implantation.
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postoperative visual function in eyes with monofocal and multifocal intraocular lenses using functional visual acuity measurement and to elucidate detailed visual function in eyes with multifocal intraocular lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional visual acuity
Key secondary outcomes
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 will undergo cataract surgery at our hospital.
Over 1.0 of expected postoperative visual acuity
Patients whose axial length is 22.5 mm and longer as well as shorter than 30 mm.
Key exclusion criteria
Patients under 20 years old,
difficulity in obtaining conscent for this study.
Patients who have systemic or ocular complications that affect their visual functions
intraoperative complicaions.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan
TEL
03-5363-
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinano-machi, Shinnjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
fwic7788@mb.infoweb.ne.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
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
慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 20 | 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
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Refraction, visual acuity, contrast visual acuity, functional visual acuity , Schirmer test, tear break up time, and slit lamp findings of the patients who are planned to undergo cataract surgery at Keio University Hospital will be evaluated preoperatively and 1 month postoperatively.
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2020 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023742
| Research Plan | |
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| 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 |
