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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AGV implantation
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site

    patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 25, 2008
    Last Updated
    October 16, 2008
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00628173
    Brief Title
    Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    May 2007 (undefined)
    Study Completion Date
    December 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site
    Intervention Type
    Procedure
    Intervention Name(s)
    AGV implantation

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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