An interventional study of Ahmed Glaucoma Implant and Trabeculectomy with Mitomycin C in Glaucoma, sponsored by Singapore Eye Research Institute. Status unknown at 1 site in Singapore. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Singapore Eye Research Institute · Not applicable, Interventional, and Treatment
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:
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.
Exclusion Criteria:
Ahmed Glaucoma Implant (AGI) surgery
Device: Ahmed Glaucoma Implant
Trabeculectomy with mitomycin C surgery
Procedure: Trabeculectomy with Mitomycin C
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
Failure
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
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Singapore Eye Research Institute