UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Title of the study (Brief title)	Effect of phacoemulsification and viscogonioplasty for the peripheral anterior synechia
Region	Japan

Condition
Condition	Primary angle closure glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Effect of breaking the peripheral anterior synechia
Key secondary outcomes	Intraocular pressure

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	Other
Interventions/Control_1	Phacoemulsification and intraocular lens implantation Goniosynechialysis using a heavy viscoelastic
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients with cataract 2 Primary angle glaucoma patients with peripheral anterior synechia greater than 180 degree by compression gonioscopy 3 Patients with uncontrolled intraocular pressure
Key exclusion criteria	1 Patients with any retinal diseases or with uveitis 2 Any glaucoma surgery except for peripheral iridotomy or iridectomy 3 Other glaucomas
Target sample size	15

Research contact person
Name of lead principal investigator	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
Address	Himeji City, Aboshi Waku 68-1
TEL	+81-79-272-8555
Email	shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
Address	Himeji City, Aboshi Waku 68-1
TEL	+81-79-272-8555
Homepage URL
Email	shunsukenakakura@yahoo.co.jp

Sponsor
Institute	Department of Ophthalmology,Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 15 Day
Anticipated trial start date	2011 Year 11 Month 19 Day
Last follow-up date	2014 Year 12 Month 30 Day
Date of closure to data entry	2014 Year 12 Month 30 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2018 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007948