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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031405
Receipt No. R000035856
Scientific Title International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/21

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Basic information
Public title International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Acronym International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Scientific Title International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Scientific Title:Acronym International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Region
Japan Asia(except Japan)

Condition
Condition Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the group in which Ahmed Glaucoma valve was performed and the group in which trabeculectomy group was performed and to clarify which surgical approach is most effective and safe for Asian glaucoma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in mean intraocular pressure. Periodic operation with failure in the following cases.
Intraocular pressure 18 or more mm Hg on two consecutive follow-up visits after 6 months IOP not reduced to 20% below baseline on two consecutive visits after 6 months
Intraocular pressure less than 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months
Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation.
Loss of light perception vision
Key secondary outcomes Number of glaucoma instillation additionally used in 60 months
60 months of the ETDRS (BCVA: best corrected visual acuity)
Number of adverse event occurrences during the study period
Number of patients who experienced vision loss of 3 or more lines of ETDRS BCVA during 60 months
As a comparison with US-TVT, the results of intraocular pressure of 21 mmHg or more

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention group: Tube shunt operation (Ahmed Glaucoma valve)
Interventions/Control_2 Control group: (trabeculectomy with mitomycin C combined)
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Age 18 to 85 years, inclusive.
Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
IOP > 18 mm Hg on 2 or more medications on at least 2 visits
Informed consent given and consent form signed.
Key exclusion criteria Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
Pregnant or nursing women
No light perception vision
Previous incisional intraocular surgery in study eye, other than uncomplicated clear corneal cataract surgery
Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty).
Iris neovascularisation or proliferative retinopathy
Primary angle closure or primary angle closure glaucoma
Iridocorneal endothelial syndrome or anterior segment dysgenesis
Epithelial or fibrous downgrowth
Aphakia
Chronic or recurrent uveitis
Severe posterior blepharitis
Unwilling to discontinue contact lens use after surgery
Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease
Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
Advanced glaucoma with MD <-20dB
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University Hospital
Division name Ophthalmology
Zip code
Address Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3
TEL 082-257-5247
Email ganka@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University Hospital
Division name Ophthalmology
Zip code
Address Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3
TEL 082-257-5247
Homepage URL
Email ganka@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization Not applicable
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT03274024
Org. issuing International ID_1 Singapore Eye Research institute
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 広島大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Related information
URL releasing protocol https://clinicaltrials.gov/ct2/show/NCT03274024
Publication of results Partially published

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
2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 21 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035856

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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