UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029297 |
|---|---|
| Receipt number | 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 | 2022/04/02 09:21:32 |
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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 | Masayuki |
| Middle name | |
| Last name | Horiguchi |
Organization
Fujita Health University
Division name
Ophthalmology
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
masayuki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Mizuguchi |
Organization
Fujita Health University
Division name
Ophthalmology
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
Homepage URL
mizu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fujita Health Univesity
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
Tel
81-0562-93-2865
f-irb@fujita-hu.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study title
Visualization of the posterior surface of the lens nucleus with triamcinolone acetonide in phacoemulsification.
number of cases
24 cases, 24 eyes.
data collection analysis.
Management information
Registered date
| 2017 | Year | 09 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
