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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029297
Receipt No. R000033416
Scientific Title Clinical study about the intraocular surgery using the adjuvant.
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/26

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Basic information
Public title Clinical study about the intraocular surgery using the adjuvant.
Acronym Clinical study about the intraocular surgery using the adjuvant.
Scientific Title Clinical study about the intraocular surgery using the adjuvant.
Scientific Title:Acronym Clinical study about the intraocular surgery using the adjuvant.
Region
Japan

Condition
Condition The disease should be taken the intraocular surgery such as cataract or retina vitreous disease and others.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of safety and efficacy about adjuvant.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
Key secondary outcomes 1.surgery time
2.complication
3.intraocular pressure
4.electroretinogram study
5.specular microscope study
6.Laser flare cell meter study
7.optical coherence tomography study

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Object:The patient should be taken the intraocular surgery such as cataract or retina vitreous disease and others.

Interventions:The adjuvant is triamcinolone,brilliant blue G,indocyanine green and fluorescein.We use the adjuvant with intraocular surgery for improve the visibility of the desired lesion.We remove the adjuvant as much as possible by the end of surgery.

Term:Several weeks from a few days hospitalization.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.The patient who was enough explained and understand this study.

2.The patient who agree this study by the free will and sign consent forms.

3.The patient who was diagnosed adjuvant is appropriate.
Key exclusion criteria The patient who judged adjuvant is inappropriate by principal investigator or member of a research project.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Horiguchi
Organization Fujita Health University
Division name Ophthalmology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL 81-0562-95-5177
Email masayuki@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Mizuguchi
Organization Fujita Health University
Division name Ophthalmology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL 81-0562-95-5177
Homepage URL
Email mizu@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization None
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
2017 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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

Management information
Registered date
2017 Year 09 Month 26 Day
Last modified on
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033416

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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