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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039232
Receipt No. 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

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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
Email 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
Email nitta.koji7001@fukui.saiseikai.or.jp

Sponsor
Institute Ophthalmology, Fukui-ken saiseikai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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