UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009198 |
|---|---|
| Receipt number | R000010453 |
| Scientific Title | Relationship research between prognosis of trabeculectomy and fibroblast derived from each patient |
| Date of disclosure of the study information | 2012/10/27 |
| Last modified on | 2012/10/27 11:06:52 |
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Basic information
Public title
Relationship research between prognosis of trabeculectomy and fibroblast derived from each patient
Acronym
Relationship research between prognosis of trabeculectomy and fibroblast derived from each patient
Scientific Title
Relationship research between prognosis of trabeculectomy and fibroblast derived from each patient
Scientific Title:Acronym
Relationship research between prognosis of trabeculectomy and fibroblast derived from each patient
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research of relationship between prognosis of trabeculectomy and drug resistance of fibroblast derived from each glaucoma patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between prognosis of trabeculectomy and resistance of fibroblast derived from each patient for mitomycin C
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Intraocular pressure of more than 21 mmHg on maximum-tolerated medical therapy
2. Patient who has progress of visual field defect
3. Written informed consent from the patient
Key exclusion criteria
1. Previously cataract extraction with intraocular lens implantation, trabeculectomy, or both
2. Pregnant or nursing women
3. No light perception
4. Active iris neovascularization or active proliferative retinopathy
5. Iridocorneal endothelial syndrome
6. Epithelial of fibrous downgrowth
7. Aphakia
8. Vitreous in the anterior chamber for which a vitrectomy is anticipated
9. Chronic and recurrent uveitis
10. Severe posterior blepharitis
11. Unwilling to discontinue contact lens use after surgery
12. Previous cyclodestructive procedure, scleral buckling procedure, or silicone oil present
13. Conjunctival scarring precluding from producing a bleb by previous several surgeries
14. Need glaucoma surgery combined with other ocular procedures (i.e., cataract surgery, penetrating keratoplasty, or retinal surgery), anticipated need for additional ocular surgery
15. Judged inappropriate for this study by physicians
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1 Seiryo-machi Aoba-ku Sendai-shi Miyagi-ken 980-8575, Japan
TEL
022-717-7294
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Watanabe |
Organization
Tohoku University Hospital
Division name
Ophthalmology
Zip code
Address
1-1 Seiryo-machi Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
022-717-7294
Homepage URL
ryo-w@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between prognosis of trabeculectomy and resistance of fibroblast derived from each patient for mitomycin C
Management information
Registered date
| 2012 | Year | 10 | Month | 27 | Day |
Last modified on
| 2012 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010453
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
