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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016749 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | lens luxation | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Ophthalmology, Kagoshima University |
Institute | |
Department |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019438 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |