The Results of Ahmed Valve Operations

Glaucoma Clinical Trial

Official title:

A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00193960
• Other study ID #: In process
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2005
• Last updated: November 29, 2005
• Start date: January 1997
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: University Health Network, Toronto
• Contact: Rony Rachmiel, M.D.
• Phone: 416-603-5317
• Email: rachmiel_r[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.

Description:

Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.

In the present study we will compare the outcome and complicatons of both the superior and the inferior approach for inserting Ahmed Valve implants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion criteria:

1. Patients at the ages of 20-85 on the date of the surgery

2. The indication for the surgery was: uncontrolled glaucoma with maximally tolerated medical therapy who did not or were not expected to respond to other surgical procedures than seton surgery.

3. Visual acuity of, at least, 20/800 before the operation.

4. Regular post operative follow ups, for at least 1 year.

5. Patients after corneal transplantation for whom the indication of valve implantation was uncontrolled glaucoma.

Exclusion Criteria:

1. A previous seton surgery in the operated eye

2. Uveitic glaucoma patients or history of uveitis in the operated or in the fellow eye.

3. Any inflammatory or ocular surface disease that could affect the healing of the conjunctiva after the surgery ( e.g: OCP)

4. Strabismus or complains of diplopia prior to the seton surgery.

5. Past history of retinal detachment surgery with scleral buckle in the operated eye

6. Past history of endophthalmitis in the operated eye.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 1) Intraocular pressure 2) visual acuity

Locations

Country	Name	City	State
Canada	Department of Ophthalmology and visual sciences, Toronto Western Hospital,	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada,