UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004615 |
|---|---|
| Receipt number | R000005509 |
| Scientific Title | Autologous Plasmin-assisted Vitrectomy for Rhegmatogenous Retinal Detachment |
| Date of disclosure of the study information | 2010/11/24 |
| Last modified on | 2010/11/24 18:54:04 |
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Basic information
Public title
Autologous Plasmin-assisted Vitrectomy for Rhegmatogenous Retinal Detachment
Acronym
Autologous Plasmin for RRD
Scientific Title
Autologous Plasmin-assisted Vitrectomy for Rhegmatogenous Retinal Detachment
Scientific Title:Acronym
Autologous Plasmin for RRD
Region
| Asia(except Japan) |
Condition
Condition
interventional study for the treatment of RRD (study is already completed)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and complication of autologous plasmin (AP) injected before vitrectomy for rhegmatogenous retinal detachment (RRD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
extent of PVD and easiness of PVD induction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
[intervention] pre-operative autologous plasmin injection and performing vitrectomy
Interventions/Control_2
[control] vitrectomy only
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
| 11 | years-old | <= |
Age-upper limit
| 53 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
eyes with rhegmantogenous retinal detachment(RRD) without posterior vitreous detachment (PVD)
Key exclusion criteria
eyes with posterior vitreous detachment (PVD)
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jang Won Heo |
Organization
Seoul National University Hospital
Division name
Ophthalmology
Zip code
Address
28 Yongon-dong, Jongno-gu, Seoul, Korea 110-744
TEL
+82-2-2072-2438
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chaerin Park |
Organization
Seoul National University Hospital
Division name
Ophthalmology
Zip code
Address
28 Yongon-dong, Jongno-gu, Seoul, Korea 110-744
TEL
+82-2-2072-2438
Homepage URL
chaerinpark@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Seoul National University Hospital
Institute
Department
Personal name
Funding Source
Organization
self
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
Seoul National University Hospital (Seoul)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 24 | 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
The extent of PVD was larger in the AP group than the control group (p=0.025) and vitreal separation was facilitated by intravitreal AP injection (p=0.034). However, easiness of PVD induction (p=0.744) and frequency of iatrogenic retinal break found in the two groups (1 eye in the AP group, 2 eyes in the control group, p= 0.530) showed no significant difference. No postoperative intraocular hemorrhage nor systemic coagulation abnormality occurred. Postoperative endophthalmitis and positive microbial culture of AP solution were not reported either. There was no significant difference in change of visual acuity and the rate of retinal reattachment between the two groups.
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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 24 | Day |
Last modified on
| 2010 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005509
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
