UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011691 |
|---|---|
| Receipt number | R000012003 |
| Scientific Title | Efficacy of brimonidine for transient IOP rise after cataract surgery |
| Date of disclosure of the study information | 2013/09/15 |
| Last modified on | 2015/03/11 13:14:11 |
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Basic information
Public title
Efficacy of brimonidine for transient IOP rise after cataract surgery
Acronym
Efficacy of brimonidine for transient IOP rise after cataract surgery
Scientific Title
Efficacy of brimonidine for transient IOP rise after cataract surgery
Scientific Title:Acronym
Efficacy of brimonidine for transient IOP rise after cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Brimonidine on inflammation and IOP of post-operative patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP
Key secondary outcomes
flare
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Brimonidine
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. Patients who are scheduled for cataract surgery.
2. Aged 20 years or more.
3. Patients who are able to visit Hiroshima University Hospital through study period.
4. Have provided a written informed consent.
Key exclusion criteria
1.Patients with glaucoma
2.Patients with a history of intraocular surgery past 6 momth.
3. Patients who have difficulty for IOP measurement with applanation tonometer.
4.Patients who with a history of uveitis, ocular infection, and severe dry eye.
5.Patients who are treated with steroids or any NSAIDs.
6. Patients who have cardiovascular disease, cerebrovascular disease, and hypotension.
7.patients with diabetes mellitus.
8. Patients who the investigator consider ineligible for enrolment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kiuchi |
Organization
Hiroshima University
Division name
Ophthalmology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
ykiuchi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ideguchi |
Organization
Hiroshima University
Division name
Ophthalmology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
Homepage URL
ideguchi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Uiversity
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Uiversity
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
| 2013 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 15 | 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
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2015 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012003
