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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:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00628173
First received: February 25, 2008
Last updated: October 16, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention
Glaucoma
 Procedure: AGV implantation

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Enrollment: 106
Study Start Date: January 2005
Estimated Study Completion Date: December 2007
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00628173     History of Changes
Other Study ID Numbers: 8417
Study First Received: February 25, 2008
Last Updated: October 16, 2008
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013