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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021559
Receipt No. R000023343
Scientific Title Trypan blue staining during ophthalmic surgery
Date of disclosure of the study information 2016/03/22
Last modified on 2016/04/08

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Basic information
Public title Trypan blue staining during ophthalmic surgery
Acronym Trypan blue staining during ophthalmic surgery
Scientific Title Trypan blue staining during ophthalmic surgery
Scientific Title:Acronym Trypan blue staining during ophthalmic surgery
Region
Japan

Condition
Condition cataract with corneal opacity, mature cataract/hypermature cataract, patients who are indicated for DSAEK/DMEK
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate visibility with trypan blue staining during ophthalmic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes visibility with trypan blue during ophthalmic surgery
Key secondary outcomes

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 Anterior capsule staining with trypan blue in cataract surgery. Graft staining with trypan blue in DSAEK/DMEK.
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) Cataract with corneal opacity, Mature cataract/Hypermature cataract, or Patients who are indicated for DSAEK/DMEK in Osaka University Hospital
2) Whether either of the following criteria is met:
i) Aged 20 years old and over, written informed consent from patient.
ii) Aged 16 to 19 years, written informed consent from patient and proxy.
iii) Under 16 years of age, informed assent from patient and written informed consent from proxy.
iv) Under 16 years of age, written informed consent from proxy.
Key exclusion criteria i) Pregnancy, possible pregnancy, or breast-feeding.
ii) Unsuitable for entry in this study judged by investigators.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohji Nishida
Organization Osaka University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL +81-6-6879-3451
Email knishida@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Oie
Organization Osaka University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL +81-6-6879-3456
Homepage URL
Email yoie@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 22 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 08 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
2016 Year 03 Month 22 Day
Last modified on
2016 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023343

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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