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

Tracking Information
First Received Date ^ICMJE	February 25, 2008
Last Updated Date	October 16, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00628173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Procedure: AGV implantation
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	106
Completion Date	December 2007
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00628173
Other Study ID Numbers ^ICMJE	8417
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Shaheed Beheshti Medical University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shaheed Beheshti Medical University
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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