GlaucomaNCT00193960
The Results of Ahmed Valve Operations
An observational study of Glaucoma, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- 1) Intraocular pressure 2) visual acuity
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 1997to Jun 2005
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Ophthalmology and visual sciences, Toronto Western Hospital,
Toronto, Ontario
Rony Rachmiel, MD, 416-603-5317, rachmiel_r@hotmail.com
Graham E Trope, MB, FRCSC
About this study
Official title: A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- 1) Intraocular pressure 2) visual acuity
- Keywords
- Seton surgery, glaucoma, Ahmed valve, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) Intraocular pressure 2) visual acuityProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 1997
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Trope E Graham, MB, FRCSC, Study director, University of Toronto, Department of OphthalmologyRony Rachmiel, M.D, Study director, University of Toronto, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193960
- Sponsor's protocol ID
- In process
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Publications
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. doi: 10.3129/i08-082.
PubMed 18711462