UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031230 |
|---|---|
| Receipt number | R000035630 |
| Scientific Title | The comparison of surgical result of cataract surgery between 3D heads-up surgery and traditional microsurgical surgery. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/05/17 12:35:08 |
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Basic information
Public title
The comparison of surgical result of cataract surgery between 3D heads-up surgery and traditional microsurgical surgery.
Acronym
The result of cataract surgery under 3D heads-up surgery
Scientific Title
The comparison of surgical result of cataract surgery between 3D heads-up surgery and traditional microsurgical surgery.
Scientific Title:Acronym
The result of cataract surgery under 3D heads-up surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the operative time of cataract surgery between the surgery under the 3D heads-up condition and traditional surgical condition
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operative time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Interventions:
the cataract surgery under the 3D heads-up condition
Interventions/Control_2
Control: the cataract srugery under the traditional microsurgical condition
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who is planning on getting cataract surgery in Kobe University Hospital
Key exclusion criteria
(1) the eye with corneal opacity
(2) the eye with poor mydriasis condition
(3) the eye with brittle Zinn's zonule
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisanori Imai |
Organization
Kobe University Hospital
Division name
Division of Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, chuo-ku, Kobe, Japan
TEL
078-382-6048
hisimai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisanori Imai |
Organization
Kobe University Hospital
Division name
Division of Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, chuo-ku, Kobe, Japan
TEL
078-382-6048
Homepage URL
hisimai@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
This research does not need any funding
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
| 2018 | Year | 04 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035630
