Status:
UNKNOWN
Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Glaucoma
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) with phacoemuls...
Detailed Description
Studies have pointed out racial differences in the outcome of conventional filtration surgery. Glaucoma drainage implants have been found to do well in Asian eyes but no randomized controlled trial is...
Eligibility Criteria
Inclusion
- Ø 21 years old and above Ø Primary Open Angle Glaucoma with Shaffer grade 2 or better for 360 degrees Ø Primary Angle Closure Glaucoma (occludable angles +/- PAS) Ø Inadequate IOP control despite maximum medical treatment (using at least 2 types or more antiglaucoma medications) and/or laser treatment in the presence of glaucomatous optic neuropathy on optic nerve head evaluation and corresponding visual field findings Ø Visually significant cataract with visual acuity of less than or equal to 6/12 Ø No corneal disease Ø Willing to be followed up for 1 year duration post-operatively Ø Informed consent
Exclusion
- Ø Secondary Glaucoma (Uveitic, Neovascular, traumatic, Iridocorneal Endothelial Syndrome); Congenital Glaucoma Ø Severe ocular disease like Proliferative Diabetic Retinopathy, Age-related Macular Degeneration Exudative type Ø Prior intraocular surgery(in the study eye) Ø Patients with small central island and temporal field remaining on perimetry Ø One-eyed patients or fellow eye with visual acuity of counting fingers (CF) or worse
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00273221
Start Date
July 1 2005
End Date
July 1 2006
Last Update
May 22 2008
Active Locations (1)
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1
National University Hospital
5 Lower Kent Ridge Road, Singapore, 119074