UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039232 |
|---|---|
| Receipt number | R000044059 |
| Scientific Title | SLT study as first-line or second-line treatment for NTG |
| Date of disclosure of the study information | 2020/01/24 |
| Last modified on | 2020/01/22 18:50:23 |
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Basic information
Public title
SLT study as first-line or second-line treatment for NTG
Acronym
SLT as first-line or second-line treatment for NTG
Scientific Title
SLT study as first-line or second-line treatment for NTG
Scientific Title:Acronym
SLT as first-line or second-line treatment for NTG
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the SLT as first-line treatment and second-line treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We may supplement instillation treatment by investigating the effect, safety of first-line SLT and the second-line SLT for NTG.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
A period of the intervention for the individual subject: One year
Quantity (a dose or dose of radioactivity): 0.8mJ *90
The number of times, frequency: Only once, first-line
Interventions/Control_2
A period of the intervention for the individual subject: One year
Quantity (a dose or dose of radioactivity): 0.8mJ *90
The number of times, frequency: Only once, second-line
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
The treatment that SLT treatment (first-line SLT treatment or second-line SLT treatment) is most suitable and the case that were judged
intraocular pressure>= 14mmHg and MD>= -15dB more than at least one time in three times most recent in patients of NTG
Cornea thickness 450-600
Age at the time of the agreement acquisition 20 years old or older
Key exclusion criteria
Using glaucoma eye drops more than two drugs (including the combination agent), and there is not a plan of the discontinuation at all anymore
Past of the laser treatment
Past of LASIK
Past of eye surgeries (but is excluded when is more than 3 months after cataract surgery)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nitta |
Organization
Fukui-ken saiseikai Hospital
Division name
Ophthalmology
Zip code
918-8503
Address
Wadanakamachi Funabashi 7-1, Fukui, Fukui
TEL
0776-23-1111
nitta.koji7001@fukui.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nitta |
Organization
Fukui-ken saiseikai Hospital
Division name
Ophthalmology
Zip code
918-8503
Address
Wadanakamachi Funabashi 7-1, Fukui, Fukui
TEL
0776-23-1111
Homepage URL
nitta.koji7001@fukui.saiseikai.or.jp
Sponsor or person
Institute
Ophthalmology, Fukui-ken saiseikai Hospital
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
Fukui-ken saiseikai Hospital
Address
Ophthalmology
Tel
0776-23-1111
nitta.koji7001@fukui.saiseikai.or.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 | 01 | Month | 24 | 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 | 11 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 01 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044059
