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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042864
Receipt No. 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 2020/12/27

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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 at 1 day 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
Email 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
Email eritakahashi@kumamoto-u.ac.jp

Sponsor
Institute Faculty of Life Sciences, Kumamoto University
Institute
Department

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 +81963735247
Email ganka@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 Preinitiation
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 01 Month 04 Day
Last follow-up date
2022 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
2020 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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