UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bleb morphology before and after phacoemulsification
Title of the study (Brief title)	Bleb morphology before and after phacoemulsification
Region	Japan

Condition
Condition	glaucoma, cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To unveil the bleb-related factors that affect IOP after cataract surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Bleb morphology one month after lens extraction
Key secondary outcomes	Bleb morphology and IOP before and after cataract surgery

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	40 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who experience trabeculectomy surgery more than one year before cataract surgery
Key exclusion criteria	Uncontrollable IOP Surgical complication
Target sample size	20

Research contact person
Name of lead principal investigator	Masaru Inatani
Organization	University of Fukui
Division name	Department of Ophthalmology
Address	Matsuoka Shimoaizuki 23-3, Eiheiji-cho, Fukui
TEL	+81-776-61-8403
Email	inatani@u-fukui.ac.jp

Public contact
Name of contact person	Satoshi Yokota
Organization	University of Fukui
Division name	Department of Ophthalmology
Address	Matsuoka Shimoaizuki 23-3, Eiheiji-cho, Fukui
TEL	+81-776-61-8403
Homepage URL
Email	stsykt@u-fukui.ac.jp

Sponsor
Institute	University of Fukui Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	福井大学医学部附属病院（福井県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 13 Day
Anticipated trial start date	2013 Year 11 Month 14 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 08 Day
Date trial data considered complete	2016 Year 11 Month 08 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cataract surgery is performed with 2.4 mm temporal corneal incision. After completion of continuous curvilinear capsulorhexis, phacoemulsification and aspiration is done, and IOL is injected in the bag. Before and after cataract surgery, bleb morphology is recorded with 3D-OCT(SS-1000, TOMEY). On the same day, bleb appearance is recorded by Indiana Bleb Appearance Grading Scale (IBAGS) and IOP is measured with applanation tonometer.

Management information
Registered date	2013 Year 11 Month 13 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014301