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NCT01741961 Clinical Trial

Long Term Outcome After Ahmed Glaucoma Valve

Glaucoma Clinical Trial

Official title:
4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01741961
Other study ID # Ahmed-LTO
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated December 3, 2012
Start date June 2006
Est. completion date October 2012

Study information
Verified date December 2012
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

Description:

The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients suffering from medically uncontrolled glaucoma

- Informed consent

Exclusion Criteria:

- healthy subjects

- under 18 years

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Ahmed valve
The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.

Locations
Country Name City State
Germany University Eye Clinic Dresden Dresden Saxony

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other reduction of glaucoma medication The number of glaucoma medication after Ahmed glaucoma valve implantation are being examined over a period of 4 years. 4 years No
Other postoperative complications Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years. 4 years No
Other need for revision operation The need for revision operations after Ahmed glaucoma valve implantation is being examined over a period of 4 years. 4 years No
Primary intraocular pressure reduction The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years. 4 years No
Secondary development of visual acuity The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years. 4 years No
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