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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024903
Receipt No. R000028393
Scientific Title Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Date of disclosure of the study information 2016/11/21
Last modified on 2017/02/25

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Basic information
Public title Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Acronym Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Scientific Title Studying the safety and effectiveness of ultrathin 34G needles in intravitreal injections.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kamei Motohiro
Organization Aichi Medical University Hospital
Division name Department of Ophthalmology, Aichi Medical University
Zip code
Address Nagakute, Aichi, Japan
TEL 0561-62-3311
Email sasajima.hirofumi.044@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sasajima Hirofumi
Organization Aichi Medical University Hospital
Division name Department of Ophthalmology, Aichi Medical University
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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