UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024903 |
|---|---|
| Receipt number | 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 20:07:12 |
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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
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
sasajima.hirofumi.044@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Aichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028393
