UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047298 |
|---|---|
| Receipt number | R000053941 |
| Scientific Title | Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2022/03/28 08:52:20 |
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Basic information
Public title
Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Acronym
Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Scientific Title
Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Scientific Title:Acronym
Baerveldt glaucoma implant with two tubes inserted into the vitreous cavity
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a new surgical technique designed to increase filtration volume with two parallel tubes and one plate of Baerveldt glaucoma implant
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, Supplementa medical therapy score
Key secondary outcomes
Corneal endothelial cell count, intraoperative and early postoperative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Double tube insertion
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Neovascular glaucoma cases
Key exclusion criteria
Previous tube shunt surgery
Target sample size
10
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
Osaka Red Cross Hospital
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
Osaka Red Cross Hospital
Address
5-30 Fudegasakicho, Tennojiku, Osaka
Tel
0667745111
masayuki@akimoto3.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
| 2022 | Year | 03 | Month | 28 | 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
10
Results
Preoperative IOP
Double: 32.0+-11.33 (4.1),
Single: 29.7+-6.31 (5.7)
At 12 months
Double: 11.8+-2.70 (0.2),
Single: 14.2+-4.05 (1.1)
Results date posted
| 2022 | Year | 03 | Month | 28 | Day |
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
| 2019 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 25 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053941
