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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Karim Damji, University of Alberta
ClinicalTrials.gov Identifier:
NCT00901108
First received: May 11, 2009
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, either done alone or combined with cataract surgery, in patients with open angle glaucoma.


Condition Intervention Phase
Open Angle Glaucoma
Procedure: Trabectome +/- Cataract Surgery
Procedure: Trabeculectomy with Mitomycin C +/- Cataract Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Mean IOP at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Surgical complication rates (intraoperative and postoperative) [ Time Frame: intraoperative, 1d, 1wk, 1m, 3m, 6m, 12m ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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, 6 months post-operative ] [ Designated as safety issue: No ]
  • Mean number of glaucoma medications [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ] [ Designated as safety issue: No ]
  • Need for additional laser (excluding suture lysis) and surgical interventions [ Time Frame: 1d, 1wk, 1m, 3m, 6m, 12m ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trab MMC +/- CE-IOL if needed Procedure: Trabeculectomy with Mitomycin C +/- 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.

For combined procedures with cataract surgery, CE-IOL will be done first, followed by Trabeculectomy with Mitomycin C.

Active Comparator: Trabectome +/- CE-IOL if needed Procedure: Trabectome +/- Cataract Surgery

Trabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways.

For combined procedures with cataract surgery, Trabectome will be done first, followed by CE-IOL because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery.


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, either done alone or combined with cataract extraction by phacoemulsification and intraocular lens implant (CE-IOL), for control of IOP in early to moderate stage OAG, including pseudoexfoliative glaucoma.

Methods: Single center, single surgeon, prospective randomized controlled trial. A total of 52 eligible participants, 26 per study arm will be recruited. Participants will be stratified based on cataract or no cataract surgery and then block randomized to either Trabectome or Trab MMC.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40-85 years
  2. Early to moderate open angle glaucoma (including pseudoexfoliative) on 2 or more topical glaucoma medications
  3. Open angles (≥ Shaffer grade II)
  4. Inadequately controlled glaucoma with IOP ≥ 18 mm Hg and ≤ 40 mm Hg on tolerated medical therapy
  5. Treatment groups undergoing combined procedure with CE-IOL: visually significant cataract must be present
  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 (eg. juvenile, pigmentary, neovascular, uveitic, traumatic, anterior chamber intraocular lens implant, aphakic)
  3. Corneal edema or other problems precluding accurate tonometry
  4. Absence of clear angle landmarks or problems that interfere with gonioscopic view (corneal opacities or external eye disease)
  5. Presence of peripheral anterior synechiae
  6. Ocular disease other than glaucoma that may affect assessments of visual acuity and visual field (eg. proliferative diabetic retinopathy, clinically significant macular edema, extensive macular degeneration)
  7. Previous angle surgery/ filtering procedure/ seton surgery
  8. Previous argon laser trabeculoplasty
  9. Concurrent use of steroids or steroid use within the preceding 3 months
  10. Presence of significant health conditions (uncontrolled diabetes, significant CAD, COPD, bleeding and clotting disorders)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901108

Contacts
Contact: Georgie G Jarvis 780 735 4986 georgie.jarvis@ualberta.ca

Locations
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Georgie G Jarvis    780 735 4986      
Principal Investigator: Karim F Damji, MD FRCSC MBA         
Sub-Investigator: Christopher J Rudnisky, MD FRCSC         
Sub-Investigator: Ezekiel Weis, MD FRCSC MPH         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Karim F Damji, MD FRCSC MBA University of Alberta
  More Information

No publications provided

Responsible Party: Karim Damji, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00901108     History of Changes
Other Study ID Numbers: UAKD-001, HREB Pro00004851
Study First Received: May 11, 2009
Last Updated: April 26, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
open angle glaucoma
trabectome
trabeculectomy
cataract

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014