UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009848 |
|---|---|
| Receipt number | R000011020 |
| Scientific Title | The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma |
| Date of disclosure of the study information | 2013/01/24 |
| Last modified on | 2016/07/27 10:21:51 |
* 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
The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma
Acronym
The efficacy of 360-degree suture trabeculotomy
Scientific Title
The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma
Scientific Title:Acronym
The efficacy of 360-degree suture trabeculotomy
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
intraocular pressure
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
| Maneuver |
Interventions/Control_1
360-degree suture trabeclotomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma patients resistance to topical glaucoma eye drop treatment
Key exclusion criteria
pregnant woman, breast-feeding woman
High degree of visual field defect (MD value under -20dB in HFA c-30-2)
Paitents with serious systemic or opthalmic complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Ohguro |
Organization
Japan Community Healthcare Organaization Osaka Hospital
Division name
Ophthalmology
Zip code
Address
4-2-78 Fukushima, Fukushima-ku, Osaka
TEL
06-6441-5451
nohguro@okn.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Ohguro |
Organization
Japan Community Healthcare Organaization Osaka Hospital
Division name
Ophthalmology
Zip code
Address
4-2-78 Fukushima, Fukushima-ku, Osaka
TEL
06-6441-5451
Homepage URL
nohguro@okn.gr.jp
Sponsor or person
Institute
Japan Community Healthcare Organaization Osaka Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organaization Osaka Hospital
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
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
| 2013 | 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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011020
