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Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Karim Damji, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Procedure: Trabectome-IOL Procedure: Trab-IOL Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Trabectome-IOL
Combined Trabectome and cataract extraction with intraocular lens insertion
Procedure: Trabectome-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.

Active Comparator: Trab-IOL
Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion
Procedure: Trab-IOL

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.

Primary Outcome Measures :
  1. Mean IOP at 6 months [ Time Frame: 6 months ]
  2. Surgical complication rates [ Time Frame: intraoperative and postoperative up to 12 months ]

Secondary Outcome Measures :
  1. Mean difference in IOP from baseline to 6 months [ Time Frame: 6 months ]
  2. Mean IOP at 12 months [ Time Frame: 12 months ]
  3. Quality of life measures [ Time Frame: preoperative and postoperative at 6 and 12 months ]
  4. Mean number of glaucoma medications [ Time Frame: 12 months ]
  5. Visual acuity [ Time Frame: 12 months ]
  6. Need for additional laser (excluding suture lysis) and surgical interventions [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 40-85 years
  2. Open angle glaucoma (including pseudo exfoliative glaucoma)
  3. Open angles (≥ Shaffer grade II)
  4. Inadequately controlled IOP requiring surgical intervention
  5. Visually significant cataract
  6. Willing to complete quality of life questionnaires
  7. Capable of informed consent and available for at least 1 year follow-up

Exclusion Criteria:

  1. Any form of angle closure glaucoma
  2. Secondary open angle glaucomas
  3. Absence of clear angle landmarks on gonioscopy
  4. Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
  5. Previous angle surgery or filtering procedure
  6. Steroid use within the preceding 3 months
  7. Presence of significant co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901108

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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Karim F Damji, MD FRCSC MBA University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Karim Damji, Professor, University of Alberta Identifier: NCT00901108     History of Changes
Other Study ID Numbers: UAKD-001
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karim Damji, University of Alberta:
open angle glaucoma
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors