Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2016-09-28
2020-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tube implant
Ahmed Glaucoma Implant (AGI) surgery
Ahmed 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
Trabeculectomy
Trabeculectomy with mitomycin C surgery
Trabeculectomy with Mitomycin C
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Interventions
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Ahmed 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
Trabeculectomy with Mitomycin C
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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National Medical Research Council (NMRC), Singapore
OTHER_GOV
Singapore Eye Research Institute
OTHER
Responsible Party
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Dr Ho Ching Lin
Research Director
Principal Investigators
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Ching Lin Ho
Role: PRINCIPAL_INVESTIGATOR
Singapore National Eye Centre
Locations
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Singapore Eye Research Institute
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R1293/99/2015
Identifier Type: -
Identifier Source: org_study_id
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