UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparison of surgical result of cataract surgery between 3D heads-up surgery and traditional microsurgical surgery.
Title of the study (Brief title)	The result of cataract surgery under 3D heads-up surgery
Region	Japan

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

Objectives
Narrative objectives1	To compare the operative time of cataract surgery between the surgery under the 3D heads-up condition and traditional surgical condition
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	operative time
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Interventions: the cataract surgery under the 3D heads-up condition
Interventions/Control_2	Control: the cataract srugery under the traditional microsurgical condition
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient who is planning on getting cataract surgery in Kobe University Hospital
Key exclusion criteria	(1) the eye with corneal opacity (2) the eye with poor mydriasis condition (3) the eye with brittle Zinn's zonule
Target sample size	52

Research contact person
Name of lead principal investigator	Hisanori Imai
Organization	Kobe University Hospital
Division name	Division of Ophthalmology
Address	7-5-2 Kusunoki-cho, chuo-ku, Kobe, Japan
TEL	078-382-6048
Email	hisimai@med.kobe-u.ac.jp

Public contact
Name of contact person	Hisanori Imai
Organization	Kobe University Hospital
Division name	Division of Ophthalmology
Address	7-5-2 Kusunoki-cho, chuo-ku, Kobe, Japan
TEL	078-382-6048
Homepage URL
Email	hisimai@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	This research does not need any funding
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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 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	2018 Year 02 Month 09 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035630