UMIN-CTR Clinical Trial

Public title

A multicenter, randomized, trial to test non-inferiority of microhook ab interno trabeculotomy against Trabectome for an intraocular pressure lowering effect and safety

Acronym

Trabectome versus Microhook ab interno Trabeculotomy Comparative Study (TramTrac Study)

Scientific Title

A multicenter, randomized, trial to test non-inferiority of microhook ab interno trabeculotomy against Trabectome for an intraocular pressure lowering effect and safety

Scientific Title:Acronym

Trabectome versus Microhook ab interno Trabeculotomy Comparative Study (TramTrac Study)

Region

Japan

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Trabectome is a standard procedure of minimally invasive glaucoma surgery (MIGS). However, a disposable handpiece used is so expensive that the procedure has not been popularized in Japan. Recently, a microhook specifically designed for ab interno trabeculotomy has been developed. Because of low cost and reusability of the microhook, the ab interno trabeculotomy using this device will reduce the medical resources and expense. The purpose of this study is to test whether the ab interno trabeculotomy using the microhook is not clinically inferior to Trabectome in terms of intraocular pressure (IOP) reduction (efficacy) and safety.

Basic objectives2

Others

Basic objectives -Others

Non-inferiority

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Duration of treatment success.
Definition: Surgery is defined as success if any "event" described blow does not happen at 1 month after surgery. Then, the duration of treatment success is defined as a duration from the operation day to a time when any one of the 4 events happens in the eye with surgey success.
Event:
1)At two consecutive visits, IOP exceeds 21mmHg or does not reach 5mmHg.
2)IOP reduction rate compared with baseline does not reach 20%.
3)Glaucoma medical therapy is augmented.
4)Additional glaucoma surgery is required.

Key secondary outcomes

Efficacy Outcome
1) Duration of treatment success defined by more stringent criteria. Thus, event 1)is defined as that at two consecutive visits, IOP exceeds 18mmHg or does not reach 5mmHg. Other 3 events are the same as those used in the primary outcome meausure.
2)Pre- and postoperative IOP at 1, 3, 6 and 12 months.
3)The number of Pre- and postoperative anti-glaucoma medications.
4)Success or failure of surgery at 12 months.
5)Presence or absence of additional glaucoma surgery.

Safety Outcomes
1) Presence, amount, and duration of hyphema
2)Presence, amount, and duration of transient postoperative IOP spike.
3)Corneal endothelial density at 12 months after surgery.
4) Other adverse events.

Other Outcomes (Expolatory Outcomes)
1) Presence and degree of peripheral anterior synechie.
2) Final IOP

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Trabectome, 75 eyes of 75 subjects

Interventions/Control_2

ab interno trabeculotomy using microhook, 75 eyes of 75 subjects

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

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Open anterior chamber angle with Shaffer classification grade III or IV
2) Ocular hypertension, primary open angle glaucoma, exfoliation syndrome, or exfoliation glaucoma
3) At screening, IOP is reproducibly equal to or more than 20 and less than 40 mmHg under at least 1 anti-glaucoma medication use
4) No history of intraocular surgery other than cataract surgery
5) Mean deviation better than -12dB, and two or less juxtafoveal points with 0 dB on the Humphrey visual field 30-2 or 24-2 program or equivalent
6) A patient who voluntarily provides us a written informed consent to participate in this study

Key exclusion criteria

1) A patient with only one functional eye
2) Inapplicability to Goldmann applanation tonometry
3) Presence or a history of uveitis
4) A patient who received oral, topical, or subTenon injection of corticosteroid within 6 months
5)Presence or a history of diabetes
6) A pacemaker recipient
7) A patient who received cataract surgery on the nominated eye withn 6 months
8) A history of laser trabeculoplasty or laser iridotomy
9) Corneal endothelial density less than 1000/mm2
10) A pregnant or breast-feeding woman, or a woman who plans to be pregnant
11) An individual who participated in other studies within 4 months
12) A patient judged to be ineligible for any reason by a doctor in charge

Target sample size

150

Name of lead principal investigator

1st name	Makoto
Middle name
Last name	Nakamura

Organization

Kobe University Hospital

Division name

Ophthalmology

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-6048

Email

manakamu@med.kobe-u.ac.jp

Name of contact person

1st name	Yuko
Middle name
Last name	Yamada

Organization

Kobe University Hospital

Division name

Ophthalmology

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-6048

Homepage URL

Email

ganka@med.kobe-u.ac.jp

Institute

Kobe University Hospital, Department of Ophthalmology

Institute

Department

Personal name

Organization

Kobe University Graduate School of Medicine, Department of Surgery, Division of Ophthalmology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kobe University Hospital Institutional Review Board

Address

7-5-2 Kusunoki-cho, CHuo-ku, Kobe, Hyogo

Tel

81-78-382-6669

Email

kainyu@med.kobe-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

秋田大学医学部附属病院（秋田県）、井上眼科病院（東京都）、愛媛大学医学部附属病院（愛媛県）、金沢大学医学部附属病院（石川県）、北里大学医学部附属病院（神奈川県）、京都大学医学部附属病院（京都府）、神戸大学医学部附属病院（神戸大学）、埼玉医科大学（埼玉県）、東北大学医学部附属病院（宮城県）、二本松眼科病院（東京都）、昭和大学医学部附属病院（東京）、島根大学医学部附属病院（島根県）

Date of disclosure of the study information

2018

Year

02

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

47

Results

Due to the COVID-19 pandemic, it is practically difficult to enroll new candidates and follow up post surgical participants. Therefore, this study has been to be terminated.

Results date posted

2020

Year

06

Month

01

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

12

Month

06

Day

Date of IRB

2020

Year

05

Month

01

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

29

Day

Last modified on

2020

Year

06

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032738