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Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

This study is currently recruiting participants.
Verified by Queen's University, May 2008

Sponsors and Collaborators: Queen's University
Glaucoma Research & Education Group
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00551902
  Purpose

In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively. The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.

Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.


Condition Intervention Phase
Glaucoma
Procedure: Trabeculectomy with anterior chamber infusion system
Procedure: Trabeculectomy without anterior chamber infusion system
Phase I

Genetics Home Reference related topics:   early-onset glaucoma   

MedlinePlus related topics:   Glaucoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • surgical success: intraocular pressure lowered by 30% and functional filtering bleb [ Time Frame: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need for laser suture lysis [ Time Frame: any point post operatively ] [ Designated as safety issue: Yes ]
  • complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing [ Time Frame: any time post operatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   90
Study Start Date:   September 2007
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Trabeculectomy with anterior chamber infusion system
Procedure: Trabeculectomy with anterior chamber infusion system
Trabeculectomy with anterior chamber infusion system
2: Active Comparator
Trabeculectomy without anterior chamber infusion system
Procedure: Trabeculectomy without anterior chamber infusion system
Standard trabeculectomy surgery

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 18 years of age
  • One of the following diagnoses:

    • primary open angle glaucoma
    • chronic angle closure glaucoma
    • pseudo exfoliation glaucoma
    • pigment dispersion glaucoma

Exclusion Criteria:

  • unable to provide consent or return for follow up
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551902

Contacts
Contact: Robert J Campbell, MD     (613) 544-3400 ext 3189     rob.campbell@queensu.ca    

Locations
Canada, Ontario
Hotel Dieu Hospital, Queen's University     Recruiting
      Kingston, Ontario, Canada, K7L 5G2
      Contact: Robert J Campbell, MD     (613) 544-3400 ext 3189     rob.campbell@queensu.ca    
      Principal Investigator: Robert J Campbell, MD            
Toronto Western Hospital, University of Toronto     Not yet recruiting
      Toronto, Ontario, Canada
      Contact: Graham E Trope, MD            

Sponsors and Collaborators
Queen's University
Glaucoma Research & Education Group

Investigators
Principal Investigator:     Robert J Campbell, MD     Queen's University    
  More Information


Responsible Party:   Queen's University ( Dr. Robert J Campbell )
Study ID Numbers:   RC-2
First Received:   October 29, 2007
Last Updated:   May 20, 2008
ClinicalTrials.gov Identifier:   NCT00551902
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Queen's University:
Glaucoma  
trabeculectomy  
anterior chamber maintainer  
anterior chamber infusion  

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on October 17, 2008




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