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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030167
Receipt No. R000032738
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
Date of disclosure of the study information 2018/02/28
Last modified on 2019/06/03

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Basic information
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
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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


Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kobe University Hospital, Department of Ophthalmology
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2018 Year 02 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
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
2017 Year 12 Month 06 Day
Date of IRB
2019 Year 02 Month 13 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
Other related information

Management information
Registered date
2017 Year 11 Month 29 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032738

Research Plan
Registered date File name
2018/11/30 290044_PRT6.0_20181105.docx

Research case data specifications
Registered date File name
2018/11/30 症例報告書 18-10-09.xlsx

Research case data
Registered date File name


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