UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021820 |
|---|---|
| Receipt number | R000025121 |
| Scientific Title | Evaluation of femtosecond laser-assisted cataract surgery with a multifocal intraocular lens |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/10/09 16:28:30 |
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Basic information
Public title
Evaluation of femtosecond laser-assisted cataract surgery with a multifocal intraocular lens
Acronym
Evaluation of femtosecond laser-assisted cataract surgery with a multifocal intraocular lens
Scientific Title
Evaluation of femtosecond laser-assisted cataract surgery with a multifocal intraocular lens
Scientific Title:Acronym
Evaluation of femtosecond laser-assisted cataract surgery with a multifocal intraocular lens
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of femtosecond laser for multifocal intraocular lens implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of complete capsulotomies without adhesions and anterior capsule tears
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Performing cataract surgery using a femtosecond laser
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
1) Patient implanted a multifocal IOL in Jikei University Hospital
2) Whether either of the following criteria is met:
Aged 20 years old and over, written informed consent from patient.
Key exclusion criteria
Exclusion criteria were patient refusal and any anticipated difficulties with examination or follow up
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Shiba |
Organization
Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
3-25-8 Nishishinmashi Minato-ku Tokyo
TEL
03-3433-1111
shiba@rb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Shiba |
Organization
Jikei University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
3-25-8 Nishishinmashi Minato-ku Tokyo
TEL
03-3433-1111
Homepage URL
shiba@rb3.so-net.ne.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Jikei 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
東京慈恵会医科大学附属病院（眼科）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025121
