UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025504 |
|---|---|
| Receipt number | R000029351 |
| Scientific Title | Self-scleral "wrap" technique for covering the glaucoma implant tube. |
| Date of disclosure of the study information | 2017/01/03 |
| Last modified on | 2018/11/22 20:31:32 |
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Basic information
Public title
Self-scleral "wrap" technique for covering the glaucoma implant tube.
Acronym
Self-scleral "wrap" technique for covering the glaucoma implant tube.
Scientific Title
Self-scleral "wrap" technique for covering the glaucoma implant tube.
Scientific Title:Acronym
Self-scleral "wrap" technique for covering the glaucoma implant tube.
Region
| Japan |
Condition
Condition
Eyes with glaucoma implant surgery.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and effectiveness of implant surgery using the scleral wrap technique.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of the implant eye with self-scleral wrap technique
Key secondary outcomes
Intraocular pressure(IOP)
Anterior segment photography
Morphology observed by anterior segment OCT
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
* Patients who had glaucoma implant surgery for the first patient
* Eye who can be covered the tube by self-scleral "wrap" method
* Those whose intraocular pressure can be measured
* The patient's consent can be obtained
Key exclusion criteria
Patients who had implant surgery more than two times.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmology
Zip code
Address
Himeji City Aboshi Waku 68-1
TEL
+81-79-272-8555
shunsukenakakura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Ophthalmology
Zip code
Address
Himeji City Aboshi Waku 68-1
TEL
079-272-8555
Homepage URL
shunsukenakakura@yahoo.co.jp
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Saneikai Tsukazaki Hospital
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
| 2017 | Year | 01 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no exposure of the scleral covered tube and IOP was also decreased sufficiently.
The tube was covered with a uniform self-sclera taken by AS-OCT.
This technique can be conveniently performed without using patch graft material.
This is a useful method because its'a self-sclera, therefore, is free from worry of melting.
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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective observational study.
Management information
Registered date
| 2017 | Year | 01 | Month | 03 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029351
