Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
Conditions
Interventions
Intervention group: Tube shunt operation (Ahmed Glaucoma valve)
Control group: (trabeculectomy with mitomycin C combined)
Sponsors
Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactYoshiaki Kiuchi
Hiroshima University Hospital Ophthalmology
Outcome results
None listed