UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011738 |
|---|---|
| Receipt number | R000013723 |
| Scientific Title | Efficacy of multifocal intraocular lens implantation for cataract patients |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2021/09/22 17:58:06 |
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Basic information
Public title
Efficacy of multifocal intraocular lens implantation for cataract patients
Acronym
Efficacy of multifocal iontraocular lens
Scientific Title
Efficacy of multifocal intraocular lens implantation for cataract patients
Scientific Title:Acronym
Efficacy of multifocal iontraocular lens
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate near and far postoperative visual acuity, satisfaction after multifocal intraocular lens implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra and postoperative complication
postoperative non-corrected visual acuity
(near, far, refraction)
satisfuction
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
implantation of multifocal intraocular lens after cataract removal
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cataract patients who understand the contents of this study
Key exclusion criteria
patients with another ocular diseases exept cataract
patients with corneal astigmatism over than -0.5D
patients who cannot understand the efficacy and disadvantage of multifocal intraocular lens
patients judged as inadequate for the participents
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Koh-Hei |
| Middle name | |
| Last name | Sonoda |
Organization
Yamaguchi University
Division name
Department of Ophthalmology
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube City
TEL
0836-22-2278
sonodak@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Morishige |
Organization
School of Medicine
Division name
Ophthalmology
Zip code
7558505
Address
1-1-1 Minami-Kogushi
TEL
0836-22-2278
Homepage URL
morishig@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Yamaguchi University Graduate 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
Center For Clinical Research. Yamaguchi University Hospital
Address
1-1-1Minami-Kogushi, Ube city, Yamaguchi prefecture
Tel
0836-22-2428
me223@yamaguchi-u.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
7
Results
For patients with a multifocal intraocular lens inserted, we listened to postoperative visual function such as distant, near and intermediate visual acuity and patient satisfaction.
We were able to examine the usefulness of multifocal intraocular lenses and the appropriateness of intraocular lens selection.
Results date posted
| 2021 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cataract patients
Participant flow
1.Surgery application
2.Cataract surgery
3.Postoperative evaluation
Adverse events
none
Outcome measures
visual acuity
Level of satisfaction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013723
