UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship of Eyelid Tension to Glaucoma
Title of the study (Brief title)	Relationship of Eyelid Tension to Glaucoma
Region	Japan

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

Objectives
Narrative objectives1	To report the postoperative results of Trabeculectomy surgery performed at Okayama University Hospital including the effect of intraocular pressure(IOP) drops and the frequency of complications. And to evaluate the influences of eyelid pressure on the results of trabeculectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Intraocular Pressure:measured by Goldmann applanation tonometer Eyelid pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	groupA hyper eyelid pressure
Interventions/Control_2	groupA normal eyelid pressure
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	glaucoma patients
Key exclusion criteria	patients with another ocular surgery In case that the informed consent was not obtained
Target sample size	30

Research contact person
Name of lead principal investigator	Naito Tomoko
Organization	Okayama University
Division name	Ophthalmology
Address	2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL	81-86-235-7297
Email	opth@cc.okayama-u.ac.jp

Public contact
Name of contact person	Miki Takako
Organization	Okayama University
Division name	Ophthalmology
Address	2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan
TEL	81-86-235-7297
Homepage URL
Email	opth@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama 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 08 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 20 Day
Anticipated trial start date	2016 Year 09 Month 20 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 08 Month 22 Day
Last modified on	2016 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025838