The Results of Ahmed Valve Operations - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00193960

Purpose

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.

Condition	Intervention
Glaucoma	Procedure: 1) Intraocular pressure 2) visual acuity

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Retrospective Study
Official Title:	A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications

Further study details as provided by University Health Network, Toronto:

Estimated Enrollment:	80
Study Start Date:	January 1997
Estimated Study Completion Date:	June 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients at the ages of 20-85 on the date of the surgery
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.
Visual acuity of, at least, 20/800 before the operation.
Regular post operative follow ups, for at least 1 year.
Patients after corneal transplantation for whom the indication of valve implantation was uncontrolled glaucoma.

Exclusion Criteria:

A previous seton surgery in the operated eye
Uveitic glaucoma patients or history of uveitis in the operated or in the fellow eye.
Any inflammatory or ocular surface disease that could affect the healing of the conjunctiva after the surgery ( e.g: OCP)
Strabismus or complains of diplopia prior to the seton surgery.
Past history of retinal detachment surgery with scleral buckle in the operated eye
Past history of endophthalmitis in the operated eye.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193960

Contacts

Contact: Rony Rachmiel, M.D.

416-603-5317

rachmiel_r@hotmail.com

Locations

Canada, Ontario
Department of Ophthalmology and visual sciences, Toronto Western Hospital,	Recruiting
Toronto, Ontario, Canada
Contact: Rony Rachmiel, MD 416-603-5317 rachmiel_r@hotmail.com
Principal Investigator: Graham E Trope, MB, FRCSC
Sub-Investigator: Rony Rachmiel, MD
Sub-Investigator: Yvonne M Buys, M.D., FRCSC
Sub-Investigator: Flanagan John, Phd

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Study Director:	Trope E Graham, MB, FRCSC	University of Toronto, Department of Ophthalmology
Study Director:	Rony Rachmiel, M.D	University of Toronto, Department of Ophthalmology

More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Rachmiel R, Trope GE, Buys YM, Flanagan JG, Chipman ML. Ahmed glaucoma valve implantation in uveitic glaucoma versus open-angle glaucoma patients. Can J Ophthalmol. 2008 Aug;43(4):462-7.

Study ID Numbers:	In process
Study First Received:	September 9, 2005
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00193960 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Seton surgery, glaucoma, Ahmed valve, intraocular pressure

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009