Glaucoma
Conditions
Brief summary
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
Detailed description
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.
Interventions
DEVICEAhmed Glaucoma Implant
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
PROCEDURETrabeculectomy with Mitomycin C
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Sponsors
National Medical Research Council (NMRC), Singapore
Singapore Eye Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma. 2. IOP \> 18 mm Hg on 2 or more medications on at least 2 visits 3. Informed consent given and consent form signed.
Exclusion criteria
1. Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits. 2. Pregnant or nursing women 3. No light perception vision 4. Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery 5. Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty) 6. Iris neovascularisation or proliferative retinopathy 7. Primary angle closure or primary angle closure glaucoma 8. Iridocorneal endothelial syndrome or anterior segment dysgenesis 9. Epithelial or fibrous downgrowth 10. Aphakia 11. Chronic or recurrent uveitis 12. Severe posterior blepharitis 13. Unwilling to discontinue contact lens use after surgery 14. Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery or neovascular disease 15. Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy 16. 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 17. Advanced glaucoma with MD \<-20dB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP | 60 months | Intraocular pressure (mmHg) |
| Best Corrected Visual Acuity (BCVA) | 60 months | ETDRS visual acuity chart (logMAR or equivalent) |
| Supplemental medication | 60 months | Number of supplemental glaucoma medications used at Month 60 |
| Adverse Events | 60 months | Number of Adverse Events during the trial |
Countries
Singapore
Contacts
Primary ContactNatalia Porporato, Fellow
Backup ContactYa Ying Ooi
Outcome results
None listed