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The Results of Ahmed Valve Operations

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ClinicalTrials.gov Identifier: NCT00193960
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : December 1, 2005
Sponsor:
Information provided by:
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment
Glaucoma Procedure: 1) Intraocular pressure 2) visual acuity

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.


Study Type : Observational
Enrollment : 80 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications
Study Start Date : January 1997
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma





Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00193960     History of Changes
Other Study ID Numbers: In process
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: September 2005

Keywords provided by University Health Network, Toronto:
Seton surgery, glaucoma, Ahmed valve, intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases