UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014370 |
|---|---|
| Receipt number | R000016722 |
| Scientific Title | Change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients with eye dieses and factors effecting the change. |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2019/06/28 14:26:02 |
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Basic information
Public title
Change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients with eye dieses and factors effecting the change.
Acronym
Change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients with eye dieses and factors effecting the change.
Scientific Title
Change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients with eye dieses and factors effecting the change.
Scientific Title:Acronym
Change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients with eye dieses and factors effecting the change.
Region
| Japan |
Condition
Condition
Eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the change in corneal biomechanical properties and intraocular pressure after intraocular surgery in patients and factors effecting the change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change in corneal biomechanical properties.
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
Subjects undergo surgery on the eye
Key exclusion criteria
Subjects with previous intraocular surgery (except cataract surgery)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kiuchi |
Organization
Hiroshima university
Division name
Department of ophthalmology and visual science institute of biomedical & health sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555(5247)
ykiuchi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Nakao |
Organization
Hiroshima university
Division name
Department of ophthalmology and visual science institute of biomedical & health sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555(5247)
Homepage URL
nakao@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of ophthalmology and visual science institute of biomedical & health sciences
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
Tsukazaki hospital
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima university Independent Ethics Committee
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1576
kasumi-kenkyu@office.hiroshima-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
広島大学病院（広島県）、ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 25 | 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
ongoing
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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016722
