UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021170 |
|---|---|
| Receipt number | R000024416 |
| Scientific Title | Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery in patient with open-angle glaucoma coexisting cataract: a 2-year prospective, randomized, comparative study |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/02/23 09:12:21 |
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Basic information
Public title
Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery in patient with open-angle glaucoma coexisting cataract: a 2-year prospective, randomized, comparative study
Acronym
Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery
Scientific Title
Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery in patient with open-angle glaucoma coexisting cataract: a 2-year prospective, randomized, comparative study
Scientific Title:Acronym
Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery
Region
| Japan |
Condition
Condition
open-angle glaucoma coexisting cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine the safety and efficacy of 360-degree suture trabeculotomy ab interno with cataract surgery in patients with open-angle glaucoma coexisting cataract.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure and the number of glaucoma medications.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
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 with cataract surgery
Interventions/Control_2
cataract surgery
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
The patients with open-angle glaucoma coexisting cataract who need cataract surgery.
Key exclusion criteria
Glaucoma except for primary open-angle glaucoma and exfoliation glaucoma.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Sato |
Organization
Sato Eye and Internal Medicine Clinic
Division name
Department of ophthalmology
Zip code
Address
4160-270 Arao, Arao City, Kumamoto
TEL
0968-65-5900
zxsato@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Sato |
Organization
Sato Eye and Internal Medicine Clinic
Division name
Department of ophthalmology
Zip code
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
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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | 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
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024416
