UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of glycerine eyedrop for reduction of corneal stromal edema durging eye surgeries
Title of the study (Brief title)	Glycerin eyedrop for reduction or corneal stromal edema
Region	Japan

Condition
Condition	Bullous keratopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of glycerine eyedrops for reduction of corneal stromal edema during corneal surgeries
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneal stromal clarity
Key secondary outcomes	Coreneal pachymetry

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	Instillation of glycerine eye drops during eye surgeries
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	Male and Female
Key inclusion criteria	Patients who undergo corneal endothelial keratoplasty,cataract surgery, or vitrectomy, revealing corneal stromal edema that can interfere intraocular surgeries.
Key exclusion criteria	Patients who have possibility to have hypersensitiviy against glycerine
Target sample size	60

Research contact person
Name of lead principal investigator	Naoko Kato
Organization	Saitama Medical University
Division name	Department of Ophthalmology
Address	Morohongo 38, Iruma, Saitama
TEL	049-276-1250
Email	naokato@saitama-med.ac.jp

Public contact
Name of contact person	Naoko Kato
Organization	Saitama Medical University
Division name	Department of Ophthalmology
Address	Morohongo 38, Iruma, Saitama
TEL	049-276-1250
Homepage URL
Email	naokato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
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 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 13 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 04 Month 20 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025351