Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
Open Angle Glaucoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma|
- Mean IOP at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Surgical complication rates [ Time Frame: intraoperative and postoperative up to 12 months ] [ Designated as safety issue: Yes ]
- Mean difference in IOP from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean IOP at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life measures [ Time Frame: preoperative and postoperative at 6 and 12 months ] [ Designated as safety issue: No ]
- Mean number of glaucoma medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Need for additional laser (excluding suture lysis) and surgical interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Trabectome-IOL
Combined Trabectome and cataract extraction with intraocular lens insertion
Trabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways.
Trabectome will be done first, followed by cataract surgery because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery.
Active Comparator: Trab-IOL
Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion
Trabeculectomy bypasses the normal aqueous outflow channels of the eye and creates an external filtration pathway (called a filtering bleb) for aqueous to drain and be reabsorbed back into the circulation. Mitomycin C is an agent used during this procedure to decrease scar formation around the new passage.
Cataract surgery will be done first, followed by Trabeculectomy with Mitomycin C.
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma (OAG). Trab MMC has been shown to effectively lower IOP, however, it can be associated with a number of serious complications, such as hypotony maculopathy, choroidal effusion or hemorrhage, and endophthalmitis, as well as less serious complications that may affect vision related quality of life such as bleb dysesthesia.
A newer technology, referred to as the Trabectome (NeoMedix Corp., San Juan Capistrano, CA), removes an arc of trabecular meshwork and inner wall of Schlemm's canal with microcautery and appears to lower IOP effectively with fewer and less serious complications than Trab MMC. However, more studies are needed to determine the long term safety and efficacy of this relatively new procedure.
In addition, for OAG patients with visually significant cataracts, either Trab MMC or Trabectome can be combined with cataract surgery.
Study Objective: To compare the efficacy and safety of Trabectome versus Trab MMC, in combination with cataract extraction by phacoemulsification and intraocular lens implant, for control of IOP in OAG, including pseudoexfoliative glaucoma.
Methods: Single center, single surgeon, prospective randomized controlled trial. A total of 52 eligible participants, 26 per study arm would need to be recruited for 90% power. One eye per study patient will be enrolled and randomized to Trabectome combined with cataract surgery (Trabectome-IOL) or Trab MMC combined with cataract surgery (Trab-IOL).
Postoperative visits will take place at the discretion of the surgeon but will include at least visits at day 1, week 1, and months 1, 3, 6, and 12. Postoperative glaucoma medications will be added in a stepped regimen as appropriate, along with additional laser or surgical procedures if needed.
Current Study Status: Enrolment has been closed due to clearer indications for each technique over time leading to lack of clinical equipoise essential for patient randomization/recruitment. This has been discussed with the data safety monitoring board who agree that it is reasonable to end enrollment and complete followup and analysis on patients already recruited in the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901108
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|Principal Investigator:||Karim F Damji, MD FRCSC MBA||University of Alberta|