UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013243
Receipt No. R000015426
Scientific Title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Date of disclosure of the study information 2014/02/24
Last modified on 2016/08/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Acronym Effect of ExPress glaucoma filtration surgery in NTG
Scientific Title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Scientific Title:Acronym Effect of ExPress glaucoma filtration surgery in NTG
Region
Japan

Condition
Condition Normal tension glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of filtration surgery with ExPress glaucoma filtration device in normal tension glaucoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IOP lowering effect evaluating IOP reduction at 3,6 and 12 months after the surgery compared to the baseline.
The number of cases who have over 20% IOP reduction at 3, 6 and 12 months postoperatively.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 glaucoma filtration surgery with Alcon ExPress glaucoma filtration device model P50PL
Interventions/Control_2
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. diagnosed as normal tension glaucoma
2. indication for ExPress glaucoma filtration surgery
3. over 20 years old age when the study agreement was obtained
4. the patients who can understand and agree with the explanatory leaflet and written informed consent verified by IRB.
Key exclusion criteria 1. pregnant and nursing women, and woman desiring future fertility during the study period
2. angle closure and secondary glaucoma
3. subject with a history of glaucoma surgery
4. subject to receive or has received penetrating keratoprasty
5. subject to have a problem for the IOP measurement with GAT
6. diagnosed as corneal dystrophy
7. subject with a history of any ocular surgery within 6 months
8. subject with infectious or non-infectious conjunctivitis, keratitis, or uveitis in one or both eyes
9. diagnosed as severe blepharitis or dry eye
10. subject with a metal allergy
11. judged as inappropriate for study subject
12. subject attended to the other clinical trial or study within 30 days before baseline visit
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Aihara
Organization Shirato Eye Clinic
Division name ophthalmology
Zip code
Address 1-1-2 Yotsuya Shinjuku Tokyo, JAPAN
TEL 03-3355-4281
Email aihara-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Tsunemitsu Senta
Organization Alcon Japan
Division name Reseach development
Zip code
Address 2-17-7 Akasaka Minato Tokyo JAPAN
TEL 03-3588-4515
Homepage URL
Email tsunemitsu.senta@alcon.com

Sponsor
Institute Alcon Japan
Institute
Department

Funding Source
Organization Alcon JAPAN
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 10 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
2014 Year 02 Month 24 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.