Clinical trial NCT00193960: The Results of Ahmed Valve Operations
Official title: A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Seton surgery, glaucoma, Ahmed valve, intraocular pressure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Ophthalmology and visual sciences, Toronto Western Hospital,
state: Ontario
Study officials:
affiliation: University of Toronto, Department of Ophthalmology
name: Trope E Graham, MB, FRCSC
role: STUDY_DIRECTOR
affiliation: University of Toronto, Department of Ophthalmology
name: Rony Rachmiel, M.D
role: STUDY_DIRECTOR
References:
citation: 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.