UMIN-CTR Clinical Trial

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
Email	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
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	IRB of Fujita Health Univesity
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
Tel	81-0562-93-2865
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033416