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

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ClinicalTrials.gov Identifier: NCT00628173
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glaucoma Procedure: AGV implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : January 2005
Primary Completion Date : May 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site
Procedure: AGV implantation
Experimental: 2
patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site
Procedure: AGV implantation




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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

ClinicalTrials.gov Identifier: NCT00628173     History of Changes
Other Study ID Numbers: 8417
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases