Recruiting

Ahmed Valve

Sponsor:

University Health Network, Toronto

Code:

NCT00193960

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

1) Intraocular pressure 2) visual acuity

Study Details

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.

Conditions

Glaucoma

Study ID

NCT00193960

Start date

Jan, 1997

Status verified date

Sep, 2005

Completion date

Jun, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Interventions and Outcome Measures

Interventions

1) Intraocular pressure 2) visual acuity

Central Contacts and Locations

Central contacts

Rony Rachmiel, M.D.

416-603-5317rachmiel_r@hotmail.com

Locations

Department of Ophthalmology and visual sciences, Toronto Western Hospital,

Recruiting

Toronto, Ontario, Canada

Contacts

Rony Rachmiel, MD

416-603-5317rachmiel_r@hotmail.com

Principal Investigator:

Graham E Trope, MB, FRCSC

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 1, 2005

Last verified

Sep, 2005

Keywords

  • Seton surgery, glaucoma, Ahmed valve, intraocular pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2005-12-01.