UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042864 |
|---|---|
| Receipt number | R000048143 |
| Scientific Title | Prospective comparative study between rispadil and brinzolamide in glaucoma for intraocular pressure elevation after trabeculotomy ab interno |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2025/01/07 15:31:56 |
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Basic information
Public title
Study for intraocular pressure elevation after glaucoma surgery
Acronym
Study for intraocular pressure elevation after glaucoma surgery
Scientific Title
Prospective comparative study between rispadil and brinzolamide in glaucoma for intraocular pressure elevation after trabeculotomy ab interno
Scientific Title:Acronym
RB study
Region
| Japan |
Condition
Condition
Primary open angle glaucoma and exfoliative glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
MIGS (minimally invasive glaucoma surgery) is less invasive than conventional glaucoma surgeries and getting popular these days. A Kahook dual blade (KDB) is a MIGS device, especially for trabeculotomy ab interno. One of the complications after trabeculotomy including trabeculotomy ab interno with KDB (KDB-trabeculotomy) is a transient intraocular pressure (IOP) increase (IOP spike). The frequency is about 5% and IOP spike is a risk factor for the progression of visual field impairment. Therefore, suppressing postoperative intraocular pressure spikes is important. IOP-lowering drugs are administered against the IOP elevation after surgery, however, anti-biotics and anti-inflammation drops are essential after surgery, so it is required to minimize drops to control the IOP.The purpose of this study is to compare two medications which have different mechanisms of action on aqueous humor outflow pathway, Ripasudil (a specific Rho-kinase inhibitor) and Brinzolamide (a carbonic anhydrase inhibitor), and assess their efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of IOP at 1 day, 1 week, 1 month, and 3 months after surgery
Key secondary outcomes
Visual acuity, number and thickness of corneal endothelium, visual field, gonioscopy, doing condition and safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ripasudil eye drop is administrated twice daily until 3 months after surgery.
Interventions/Control_2
Brinzolamide eye drop is administrated twice daily until 3 months after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are adult patients with primary open angle glaucoma or exfoliative glaucoma who approved as an indication for KDB-trabeculotomy at a preoperative conference and obtained the consent for this study in the document at the Kumamoto University Hospital and whose IOP after surgery is 12 mmHg or higher.
Key exclusion criteria
Exclusion criteria are cases who have difficulty obtaining consent for this study due to mental diseases, or reliable inspection data e.g. due to corneal diseases, who have a contraindication for Ripasuril and Brimonidine, and whose IOP is 20 mmHg or more at 1 day after surgery.
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Inoue |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Ophthalmology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-city
TEL
+81963735247
noel@da2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Takahashi |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Ophthalmology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-city
TEL
+81963735247
Homepage URL
eritakahashi@kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumamoto city
Tel
+81963735966
byi-senshin@jimu.kumamoto-u.ac.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
| 2021 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048143
