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The Results of Ahmed Valve Operations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00193960
First received: September 9, 2005
Last updated: November 29, 2005
Last verified: September 2005
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications

Resource links provided by NLM:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014