The Results of Ahmed Valve Operations | NCT00193960

Studies
The Results of Ahmed Valve Operations

NCT00193960

Sponsor

University Health Network, Toronto

Status

Unknown status

Last Update Posted

Dec 1, 2005Estimated

Enrollment

Phase

Not provided

Conditions

Glaucoma

Interventions

1) Intraocular pressure 2) visual acuity

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1997

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2005

Last Update Posted Date

Dec 1, 2005Estimated

Description Module

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

In the present study we will compare the outcome and complicatons of both the superior and the inferior approach for inserting Ahmed Valve implants.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
1) Intraocular pressure 2) visual acuity	Procedure

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rony Rachmiel, M.D.	Contact	416-603-5317		rachmiel_r@hotmail.com

Overall Officials

Name	Affiliation	Role
Trope E Graham, MB, FRCSC	University of Toronto, Department of Ophthalmology	Study Director
Rony Rachmiel, M.D	University of Toronto, Department of Ophthalmology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology and visual sciences, Toronto Western Hospital,	Recruiting	Toronto	Ontario		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18711462	Derived	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D014787	Vision Tests
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis