UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032396 |
|---|---|
| Receipt number | R000036767 |
| Scientific Title | Comparison of clinical outcomes between ICL KS-AquaPORT V5 and conventional V4 model |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/04/26 18:03:30 |
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Basic information
Public title
Comparison of clinical outcomes between ICL KS-AquaPORT V5 and conventional V4 model
Acronym
Comparison between ICL V5 and V4 model
Scientific Title
Comparison of clinical outcomes between ICL KS-AquaPORT V5 and conventional V4 model
Scientific Title:Acronym
Comparison between ICL V5 and V4 model
Region
| Japan |
Condition
Condition
myopia and myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy and safety
Basic objectives2
Others
Basic objectives -Others
Subjective visual symptoms after surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
uncorrected visual acuity, corrected visual acuity, intraocular pressure
Key secondary outcomes
questionnaire about vision after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Surgery using ICL V4 model is performed in one
eye.
Interventions/Control_2
Surgery using ICL V5 model is performed in the
other eye.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
myopia or myopic astigmatism
Key exclusion criteria
Glaucoma
Diabetic retinopathy
Inflammatory ocular disease including uveitis
pregnant woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kojima |
Organization
Nagoya Eye Clinic
Division name
Ophthalmology
Zip code
Address
25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL
0120-758-049
tkojkoj@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Sawada |
Organization
Ophthalmology
Division name
Executive department
Zip code
Address
25-1 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
TEL
0120-758-049
Homepage URL
sawada@lasik.jp
Sponsor or person
Institute
Nagoya Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
北里大学 眼科学教室（神奈川県）、 神戸神奈川アイクリニック（東京）、 名古屋アイクリニック（愛知県）、 山王病院 眼科（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036767
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
