UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016749 |
|---|---|
| Receipt number | R000019438 |
| Scientific Title | Perfluorocarbon-Assisted vitrectomy for the management of lens luxation |
| Date of disclosure of the study information | 2015/03/16 |
| Last modified on | 2019/03/12 16:06:04 |
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Basic information
Public title
Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Acronym
Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Scientific Title
Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Scientific Title:Acronym
Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Region
| Japan |
Condition
Condition
lens luxation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety about perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication, visual acuity
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
From February 20 in 2015 to December 31, 2017. Vitrectomy and lensectomy using perfluorocarbon liquid, 1vial(5ml), for lens luxation. The times and the frequency are once.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary lens luxation
Key exclusion criteria
including retinal disorders
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | TAIJI |
| Middle name | |
| Last name | SAKAMITO |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
8908520
Address
8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL
+81-99-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
8908520
Address
8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL
+81-99-275-5402
Homepage URL
yyamatos@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Ophthalmology, Kagoshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
8-35-1 Sakruagaoka, Kagoshima
Tel
099-275-5402
yyamatos@m.kufm.kagoshima-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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
No data
Publication of results
Unpublished
Result
URL related to results and publications
No data
Number of participants that the trial has enrolled
12
Results
No data
Results date posted
| 2019 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No data
Participant flow
No data
Adverse events
No data
Outcome measures
No data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019438
