A Phase 3 interventional study of Trabectome-IOL and Trab-IOL in Open Angle Glaucoma, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-25.
Sponsored by University of Alberta · Phase 3, Interventional, and Treatment
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 19 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Exclusion Criteria:
Combined Trabectome and cataract extraction with intraocular lens insertion
Procedure: Trabectome-IOL
Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion
Procedure: Trab-IOL
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.
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
Plan to share: No
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of Alberta