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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007152
Receipt No. R000008422
Scientific Title The Efficacy of pretretment with ocular-hypotensive agants on the patients with cataract surgery
Date of disclosure of the study information 2012/02/14
Last modified on 2019/08/07

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Basic information
Public title The Efficacy of pretretment with ocular-hypotensive agants on the patients with cataract surgery
Acronym The Efficacy of ocular-hypotensive agants on post cataract surgery
Scientific Title The Efficacy of pretretment with ocular-hypotensive agants on the patients with cataract surgery
Scientific Title:Acronym The Efficacy of ocular-hypotensive agants on post cataract surgery
Region
Japan

Condition
Condition The patients with cataract surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To inevstigate whether pretretment of ocular-hypotensive agents contribute the post operatinve intraocular pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes intraocular pressure
Key secondary outcomes Change of intraocular pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ocular hypotensive agents
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 accepted catract-surgery
2)Regardless of sex.
3)Aged 20 years or more.
4)Outpatients.
"
Key exclusion criteria 1)Patinets who with a history of allergy (i.e. hypersensitivity) to the drugs to be used during the study period.
2)Patinets who need wearing contact lenses during the study period.
"
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kanamoto
Organization Hiroshima University
Division name Depertment of Ophthalomology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Depertment of Ophthalomology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Email

Sponsor
Institute Depertment of Ophthalomology, Hiroshima University
Institute
Department

Funding Source
Organization Depertment of Ophthalomology, Hiroshima University
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
Email

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
2012 Year 02 Month 14 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
2012 Year 12 Month 14 Day
Date of IRB
2012 Year 12 Month 14 Day
Anticipated trial start date
2012 Year 12 Month 14 Day
Last follow-up date
2015 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 27 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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