UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ILM Blue assisted membrane peeling in vitrectomy
Title of the study (Brief title)	ILM Blue assisted membrane peeling in vitrectomy
Region	Japan

Condition
Condition	macular hole, epiretinal membrane, macular edema, retinoschisis, retinal detachment
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the safety and the efficacy of ILM Blue assisted membrane peeling
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the frequency and the content of adverse effects
Key secondary outcomes	visual acuity change in 1, 3, and 12 months after surgery visual field change in 3 and 12 months after surgery the quality of ILM staining the rate of complete ILM peeling the rate of macular hole

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	ILM staining with ILM Blue
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the diagnosis of macular hole, macular edema, epiretinal membrane, retinoschisis, or retinal detachment by slit lamp microscopy, fundusscopy, and optical coherence tomography. And required surgical treatment.
Key exclusion criteria	1.2 or better of visual acuity the patients with glaucoma younger than 20 years old, nursing women, pregnancy
Target sample size	150

Research contact person
Name of lead principal investigator	Suzuma Kiyoshi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	54ShogoinKawaharacho, Sakyo, Kyoto, Japan
TEL	075-751-3248
Email	suzuma@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Ai Higashiyama
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	54ShogoinKawaharacho, Sakyo, Kyoto, Japan
TEL	075-751-3250
Homepage URL
Email	ahigashi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine, Department of Ophthalmology and Visual Science
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	donation money for research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 07 Day
Anticipated trial start date	2015 Year 01 Month 01 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	2014 Year 10 Month 07 Day
Last modified on	2016 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000017879