UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021169 |
|---|---|
| Receipt number | R000024363 |
| Scientific Title | Comparative study of suture trabeculotomy ab interno by the difference of incision width: 180-degree vs 360-degree Prospective, randomized and comparative study |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2021/02/27 10:18:32 |
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Basic information
Public title
Comparative study of suture trabeculotomy ab interno by the difference of incision width: 180-degree vs 360-degree
Prospective, randomized and comparative study
Acronym
Comparative study of suture trabeculotomy ab interno by the difference of incision width
Scientific Title
Comparative study of suture trabeculotomy ab interno by the difference of incision width: 180-degree vs 360-degree
Prospective, randomized and comparative study
Scientific Title:Acronym
Comparative study of suture trabeculotomy ab interno by the difference of incision width
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of suture trabeculotomy ab interno by the difference of incision width.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure and number of glaucomatous medications in postoperative one year.
Key secondary outcomes
complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
360-degree suture trabeculotomy ab interno
Interventions/Control_2
180-degree suture trabeculotomy ab interno
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
Patients with glaucoma to treat by suture trabeculotomy ab interno.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TOMOKI |
| Middle name | |
| Last name | SATO |
Organization
Sato Eye and Internal Medicine Clinic
Division name
Department of ophthalmology
Zip code
8640041
Address
4160-270 Arao, Arao City, Kumamoto
TEL
0968-65-5900
zxsato@gmail.com
Public contact
Name of contact person
| 1st name | TOMOKI |
| Middle name | |
| Last name | SATO |
Organization
Sato Eye and Internal Medicine Clinic
Division name
Department of ophthalmology
Zip code
8640041
Address
4160-270 Arao, Arao City, Kumamoto
TEL
0968-65-5900
Homepage URL
zxsato@gmail.com
Sponsor or person
Institute
Sato Eye and Internal Medicine Clinic
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
Sato Eye and Intermedicine Clinic
Address
4160-270, Arao, Arao City, Kumamoto
Tel
0968655900
zxsato@gmail.com
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
| 2016 | Year | 02 | Month | 25 | 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
100
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | 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
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2021 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024363
