UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015145 |
|---|---|
| Receipt number | R000017610 |
| Scientific Title | Clinical trial for visual function and safety evaluation:Artificial posterior capsule construction surgery and Intraocular lens implantation with 10-0 Polypropylene surgical suture which have been used for Scleral suture fixation of intraocular lenses |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2014/09/12 16:42:16 |
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Basic information
Public title
Clinical trial for visual function and safety evaluation:Artificial posterior capsule construction surgery and Intraocular lens implantation with 10-0 Polypropylene surgical suture which have been used for Scleral suture fixation of intraocular lenses
Acronym
Clinical trial for visual function and safety evaluation:Artificial posterior capsule construction surgery and Intraocular lens implantation
Scientific Title
Clinical trial for visual function and safety evaluation:Artificial posterior capsule construction surgery and Intraocular lens implantation with 10-0 Polypropylene surgical suture which have been used for Scleral suture fixation of intraocular lenses
Scientific Title:Acronym
Clinical trial for visual function and safety evaluation:Artificial posterior capsule construction surgery and Intraocular lens implantation
Region
| Japan |
Condition
Condition
aphakia
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety,efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy of visual fanction,freqency of intraoperative and postoperative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Artificial posterior capsule construction surgery and Intraocular lens implantation
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) patiants with aphakia
2) not less than age of 20
3) male and female
4) patiants who take informed consent
Key exclusion criteria
1) patiants who is inappropriate for this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Sonoda |
Organization
Yamaguchi university hospital
Division name
ophthalmology
Zip code
Address
yamaguchi prefecture ube city minamikogushi 1 1 1 Yamaguchi university ophthalmology
TEL
0836222278
sonodak@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mmichio Matsunaga |
Organization
Yamaguchi university hospital
Division name
ophthalmology
Zip code
Address
yamaguchi prefecture ube city minamikogushi 1 1 1 Yamaguchi university ophthalmology
TEL
0836222278
Homepage URL
michio_nchu214@yahoo.co.jp
Sponsor or person
Institute
Yamaguchi university hospitalophthalmology
Institute
Department
Personal name
Funding Source
Organization
trust accounts
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 12 | 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
| 2014 | Year | 09 | Month | 12 | Day |
Last modified on
| 2014 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017610
