UMIN-CTR Clinical Trial

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

Primary open angle glaucoma and exfoliative glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kumamoto University

Address

1-1-1, Honjo, Chuo-ku, Kumamoto city

Tel

+81963735966

Email

byi-senshin@jimu.kumamoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

12

Month

27

Day

Last modified on

2024

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048143