Clinical Trial: Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma

Brief Summary: 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.

Detailed Summary:

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 i
Sponsor: University of Alberta

Current Primary Outcome:

  • Mean IOP at 6 months [ Time Frame: 6 months ]
  • Surgical complication rates [ Time Frame: intraoperative and postoperative up to 12 months ]


Original Primary Outcome:

  • Mean IOP at 6 months [ Time Frame: 6 months ]
  • Surgical complication rates (intraoperative and postoperative) [ Time Frame: intraoperative, 1d, 1wk, 1m, 3m, 6m, 12m ]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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, 6 months post-operative ]
  • Mean number of glaucoma medications [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ]
  • Visual acuity [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ]
  • Need for additional laser (excluding suture lysis) and surgical interventions [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ]


Information By: University of Alberta

Dates:
Date Received: May 11, 2009
Date Started: November 2009
Date Completion:
Last Updated: February 23, 2016
Last Verified: February 2016