UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Title of the study (Brief title)	Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Region	Japan

Condition
Condition	age-related macular degeneration, macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Studying safety and efficacy of 34-G needle compared with 30-G needle in intravitreal injections
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain
Key secondary outcomes	intraocular pressure, puncture resistance,vitreal reflux,subconjunctival hemorrhage

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	comparison of intravitreal injections between using 30G needles vs 34G needles.
Interventions/Control_2	comparison of intravitreal injections between using 30G needles vs 34G needles.
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	20 years of age or older Patients with age-related macular degeneration or macular edema who needed two consecutive intravitreal injections.
Key exclusion criteria	none in particular
Target sample size	140

Research contact person
Name of lead principal investigator	Kamei Motohiro
Organization	Aichi Medical University Hospital
Division name	Department of Ophthalmology, Aichi Medical University
Address	Nagakute, Aichi, Japan
TEL	0561-62-3311
Email	sasajima.hirofumi.044@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	Sasajima Hirofumi
Organization	Aichi Medical University Hospital
Division name	Department of Ophthalmology, Aichi Medical University
Address	Nagakute, Aichi, Japan
TEL	0561-62-3311
Homepage URL
Email	sasajima.hirofumi.044@mail.aichi-med-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Aichi Medical University
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	2016 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 29 Day
Anticipated trial start date	2016 Year 10 Month 12 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 11 Month 18 Day
Last modified on	2017 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028393