Unique ID issued by UMIN | UMIN000031405 |
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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 |
International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
International collaborative randomized parallel group comparison test on efficacy and safety of tube shunt surgery using Ahmed Glaucoma valve as initial glaucoma surgery
Japan | Asia(except Japan) |
Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
Ophthalmology |
Others
NO
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
Safety,Efficacy
Others
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
YES
2
Treatment
Maneuver |
Intervention group: Tube shunt operation (Ahmed Glaucoma valve)
Control group: (trabeculectomy with mitomycin C combined)
18 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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
10
1st name | Yoshiaki |
Middle name | |
Last name | Kiuchi |
Hiroshima University Hospital
Ophthalmology
7348551
Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3
082-257-5247
ganka@hiroshima-u.ac.jp
1st name | Yoshiaki |
Middle name | |
Last name | Kiuchi |
Hiroshima University Hospital
Ophthalmology
7348551
Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3
082-257-5247
ganka@hiroshima-u.ac.jp
Hiroshima University Hospital
Not applicable
Other
Hiroshima Univesity Hospital
Hiroshima, Hiroshima Prefecture Minami-ku, Kasumi 1-2-3
082-257-5247
ganka@hiroshima-u.ac.jp
YES
NCT03274024
Singapore Eye Research institute
広島大学病院
2018 | Year | 03 | Month | 01 | Day |
https://clinicaltrials.gov/ct2/show/NCT03274024
Partially published
10
No longer recruiting
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 03 | Month | 01 | Day |
2023 | Year | 02 | Month | 28 | Day |
2025 | Year | 01 | Month | 30 | Day |
2018 | Year | 02 | Month | 21 | Day |
2023 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035856
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