UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023715 |
|---|---|
| Receipt number | R000025838 |
| Scientific Title | Relationship of Eyelid Tension to Glaucoma |
| Date of disclosure of the study information | 2016/08/22 |
| Last modified on | 2016/08/22 17:51:05 |
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Basic information
Public title
Relationship of Eyelid Tension to Glaucoma
Acronym
Relationship of Eyelid Tension to Glaucoma
Scientific Title
Relationship of Eyelid Tension to Glaucoma
Scientific Title:Acronym
Relationship of Eyelid Tension to Glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To report the postoperative results of Trabeculectomy surgery performed at Okayama University Hospital including the effect of intraocular pressure(IOP) drops and the frequency of complications. And to evaluate the influences of eyelid pressure on the results of trabeculectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Intraocular Pressure:measured by Goldmann applanation tonometer
Eyelid pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
groupA hyper eyelid pressure
Interventions/Control_2
groupA normal eyelid pressure
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
glaucoma patients
Key exclusion criteria
patients with another ocular surgery
In case that the informed consent was not obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naito Tomoko |
Organization
Okayama University
Division name
Ophthalmology
Zip code
Address
2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL
81-86-235-7297
opth@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Takako |
Organization
Okayama University
Division name
Ophthalmology
Zip code
Address
2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL
81-86-235-7297
Homepage URL
opth@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 08 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 22 | Day |
Last modified on
| 2016 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025838
