NCT00628173

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
Last Updated

October 17, 2008

Status Verified

February 1, 2008

Enrollment Period

2.3 years

First QC Date

February 25, 2008

Last Update Submit

October 16, 2008

Conditions

Glaucoma

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: AGV implantation

2

EXPERIMENTAL

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

Procedure: AGV implantation

Interventions

AGV implantationPROCEDURE
12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with refractory glaucoma who need AGV implantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 4, 2008

Study Start

January 1, 2005

Primary Completion

May 1, 2007

Study Completion

December 1, 2007

Last Updated

October 17, 2008

Record last verified: 2008-02