Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled glaucoma, who may or may not have had previous clear corneal cataract surgery with intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment groups will be made using following parameters: 1. Intraocular pressure 2. Need for supplemental medical therapy 3. Incidence of short and long term surgical complications and need for re-operation. 4. Visual function (Visual acuity and Visual field) Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with medically uncontrolled glaucoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Singapore Eye Research Institute
Singapore, Singapore
RECRUITINGFailure
Failure defined by ANY of the following criteria: * IOP ≥ 18 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 * IOP ≤ 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
Time frame: 6 months
IOP
Intraocular pressure (mmHg)
Time frame: 60 months
Best Corrected Visual Acuity (BCVA)
ETDRS visual acuity chart (logMAR or equivalent)
Time frame: 60 months
Supplemental medication
Number of supplemental glaucoma medications used at Month 60
Time frame: 60 months
Adverse Events
Number of Adverse Events during the trial
Time frame: 60 months
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