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Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628173
First Posted: March 4, 2008
Last Update Posted: October 17, 2008
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.
Information provided by:
Shahid Beheshti University of Medical Sciences
February 25, 2008
March 4, 2008
October 17, 2008
January 2005
May 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00628173 on ClinicalTrials.gov Archive Site
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Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior
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Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the superior versus inferior quadrants.

Methods: In a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications, complications and success rate (defined as at least 30% IOP reduction below preoperative values and 5<IOP<22 mmHg with or without glaucoma medications). Other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.

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Interventional
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Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Glaucoma
Procedure: AGV implantation
  • Experimental: 1
    patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site
    Intervention: Procedure: AGV implantation
  • Experimental: 2
    patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site
    Intervention: Procedure: AGV implantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with refractory glaucoma who need AGV implantation

Exclusion Criteria:

  • Eyes with less than 3 months follow-up
  • Severe conjunctival adhesions and scarring for the site of surgery
  • Presence of thin sclera and staphyloma for the site of surgery
  • The presence or anticipated need for silicone oil for superior implantation
  • Active neovascular glaucoma for inferior implantation
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT00628173
8417
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Shahid Beheshti University of Medical Sciences
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Shahid Beheshti University of Medical Sciences
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP