UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047378 |
|---|---|
| Receipt number | R000054041 |
| Scientific Title | Fixing the tube position of glaucoma drainage device into the vitreous cavity using redundant part of tube |
| Date of disclosure of the study information | 2022/04/04 |
| Last modified on | 2024/04/08 18:46:36 |
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Basic information
Public title
Fixing the tube position of glaucoma drainage device into the vitreous cavity using redundant part of tube
Acronym
Tube fixation to the vitreous cavity using redundant part
Scientific Title
Fixing the tube position of glaucoma drainage device into the vitreous cavity using redundant part of tube
Scientific Title:Acronym
Tube fixation to the vitreous cavity using redundant part
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the redundant part of the tube to control the position and orientation of the tube, we aim to ensure the reliability of the surgical technique and to reduce the risk of complications by ensuring the visibility of the tube and facilitating follow-up observation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Intraocular pressure
Tube fixation position
Key secondary outcomes
Corneal endothelial cell count, intraoperative and early postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Normal linear tube insertion
Interventions/Control_2
Tube fixation using redundant part
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with glaucoma requiring tube shunt surgery while fixing into the vitreous cavity is applicable
Key exclusion criteria
Corneal endothelial cell density less than 1000 /mm2
Phakic while cataract surgery is not applicable.
Cases for which tube shunt surgery is not applicable by any other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennojiku
TEL
0667745111
masayuki@akimoto3.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennojiku
TEL
0667745111
Homepage URL
masayuki@akimoto3.com
Sponsor or person
Institute
Osaka Red Cross Hospital
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
IRB board of Osaka Red Cross Hospital
Address
Osaka Red Cross Hospital
Tel
06-6774-5111
soumudaiichi@osaka-med.jrc.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
| 2022 | Year | 04 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054041
