UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trypan blue staining during ophthalmic surgery
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kohji Nishida
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
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	Yoshinori Oie
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000023343