UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020654 |
|---|---|
| Receipt number | R000023837 |
| Scientific Title | Assesment for quantifying posterior capsule opacification after cataract and glaucoma surgery |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2016/01/20 15:43:48 |
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Basic information
Public title
Assesment for quantifying posterior
capsule opacification after cataract and glaucoma surgery
Acronym
Assesment for quantifying posterior
capsule opacification after cataract and glaucoma surgery
Scientific Title
Assesment for quantifying posterior
capsule opacification after cataract and glaucoma surgery
Scientific Title:Acronym
Assesment for quantifying posterior
capsule opacification after cataract and glaucoma surgery
Region
| Japan |
Condition
Condition
glaucoma
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assesment for quantifying posterior
capsule opacification
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
after cataract
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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 iTec
Interventions/Control_2
groupB iSert
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
glaucoma and cataract patients
Possible obtain patients consent
Key exclusion criteria
patients with ocular surgery
Target sample size
50
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 | 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
Homepage URL
opth@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
AMO
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 | 01 | Month | 21 | 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
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023837
