UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031405
Receipt number 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 2023/08/31 15:24:41

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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 Yoshiaki
Middle name
Last name Kiuchi

Organization

Hiroshima University Hospital

Division name

Ophthalmology

Zip code

7348551

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 Yoshiaki
Middle name
Last name Kiuchi

Organization

Hiroshima University Hospital

Division name

Ophthalmology

Zip code

7348551

Address

Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3

TEL

082-257-5247

Homepage URL


Email

ganka@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



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

Hiroshima Univesity Hospital

Address

Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3

Tel

082-257-5247

Email

ganka@hiroshima-u.ac.jp


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

10

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

No longer recruiting

Date of protocol fixation

2018 Year 01 Month 18 Day

Date of IRB

2018 Year 01 Month 18 Day

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

2025 Year 01 Month 30 Day

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

2023 Year 08 Month 31 Day



Link to view the page

Value
https://center6.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