UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024194 |
|---|---|
| Receipt number | R000027851 |
| Scientific Title | Randomized controlled trial to assess the correlation between needle gauge and pain in intravitreal injection. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2017/10/03 16:45:43 |
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Basic information
Public title
Randomized controlled trial to assess the correlation between needle gauge and pain in intravitreal injection.
Acronym
Needle gauge and pain in intravitreal injection.
Scientific Title
Randomized controlled trial to assess the correlation between needle gauge and pain in intravitreal injection.
Scientific Title:Acronym
Needle gauge and pain in intravitreal injection.
Region
| Japan |
Condition
Condition
age-related macular degeneration
myopic choroidal neovascularization
Diabetic retinopathy
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether smaller gauge needle could reduce the pain in intravitreal injection or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain scale score associated with intravitreal injection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intravitreal injections with 30 gauge needle.
Interventions/Control_2
Intravitreal injections with 31 gauge needle.
Interventions/Control_3
Intravitreal injections with 32 gauge needle.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects who match the following conditions.
1)Cases diagnosed as age-related macular degeneration, myopic choroidal neovascularization, diabetic retinopathy or retinal vein occlusion.
2)Age between 40 and 90.
3)No restriction of gender
4)The patients with written informed consent.
Key exclusion criteria
The subjects who match any of the following conditions.
1)The patients who are unable to judge pain degree.
2)The patients with no written informed consent.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Honda |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL
078-382-6048
sighonda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kawaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL
078-382-6048
Homepage URL
ganka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Other
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 | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027851
