UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of eye treatment method using amniotic membrane
Title of the study (Brief title)	Treatment using amniotic membrane
Region	Japan

Condition
Condition	Corneal scleral perforation, Infectious keratoconjunctivitis, Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of development and effectiveness of the new technique the clinical effects are expected
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amniotic menbrane is expected utility as instead of the corneal donor
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	It is scheduled to undergo a Caesarean section at Tohoku University Hospital,who was to give a consent to this study.
Key exclusion criteria	Minor Adult who does not have sufficient judgment Unconscious adult person Adult's attention must be paid to the disease name
Target sample size	20

Research contact person
Name of lead principal investigator	Shunji Yokokura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	1-2 Seiryocho Aobaku Sendai Miyagi
TEL	022-717-7294
Email	yokokura@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Shunji Yokokura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	1-2 Seiryocho Aobaku Sendai Miyagi
TEL	022-717-7294
Homepage URL
Email	yokokura@oph.med.tohoku.ac.jp

Sponsor
Institute	Department of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine
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	2016 Year 03 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 11 Day
Anticipated trial start date	2016 Year 03 Month 11 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	Recruitment methods of the subject (on top of the hospitalization at our facility, is scheduled to undergo a Caesarean section, meet the selection criteria, cases of consent) The amniotic membrane is not risk for a tissue that is normally discarded during the Caesarean section, there is no privacy problems such for performing the coupling impossible anonymization.

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2016 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024725