Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
|ClinicalTrials.gov Identifier: NCT00901108|
Recruitment Status : Terminated (Slow study recruitment and lack of clinical equipoise over time)
First Posted : May 13, 2009
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma||Procedure: Trabectome-IOL Procedure: Trab-IOL||Phase 3|
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: The clinical trial was terminated early due to slow recruitment and clearer indications for each technique over time leading to lack of clinical equipoise essential for patient randomization/recruitment. This had been discussed and agreed upon with our data safety monitoring board. A total of 19 participants were recruited with followup to one year. Study analysis is pending.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||October 2015|
U.S. FDA Resources
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.
- Mean IOP at 6 months [ Time Frame: 6 months ]
- Surgical complication rates [ Time Frame: intraoperative and postoperative up to 12 months ]
- Mean difference in IOP from baseline to 6 months [ Time Frame: 6 months ]
- Mean IOP at 12 months [ Time Frame: 12 months ]
- Quality of life measures [ Time Frame: preoperative and postoperative at 6 and 12 months ]
- Mean number of glaucoma medications [ Time Frame: 12 months ]
- Visual acuity [ Time Frame: 12 months ]
- Need for additional laser (excluding suture lysis) and surgical interventions [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901108
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|Principal Investigator:||Karim F Damji, MD FRCSC MBA||University of Alberta|