UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041290 |
|---|---|
| Receipt number | R000047038 |
| Scientific Title | The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery |
| Date of disclosure of the study information | 2020/08/03 |
| Last modified on | 2020/08/03 16:07:41 |
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Basic information
Public title
The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Acronym
The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Scientific Title
The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Scientific Title:Acronym
The comparison of incisions for trabecular meshwork in minimally invasive glaucoma surgery
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incision for trabecular meshwork after trabeculotomy using Kahook dual brade or trabeculotomy micro hook
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cross-sectional area of incision for trabecular meshwork
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
| Maneuver |
Interventions/Control_1
Ab interno trabeculotomy with Kahook dual brade
Interventions/Control_2
Ab interno trabeculotomy with micro hook
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
1. The patients with primary open angle glaucome or exfoliation glaucoma
2. The patients with cataract
Key exclusion criteria
1. History of glaucoma surgery (including laser treatment)
2. History of vitreous surgery
3. History of cataract surgery
4. Those who are pregnant, breastfeeding, who may be pregnant, and who wish to become pregnant during the study period
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Arimura |
Organization
Faculty of medical science, university of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-3111
leo33@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Arimura |
Organization
Faculty of medical science, university of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8400
Homepage URL
leo33@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Faculty of medical science, university of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776-61-3111
rinsho-rinri@ml.u-fukui.ac.jp
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
| 2020 | Year | 08 | Month | 03 | 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
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047038
