Long Term Outcome After Ahmed Glaucoma Valve

December 3, 2012 updated by: Dr. Karin Pillunat, Technische Universität Dresden

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • University Eye Clinic Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.

Description

Inclusion Criteria:

  • Patients suffering from medically uncontrolled glaucoma
  • Informed consent

Exclusion Criteria:

  • healthy subjects
  • under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
glaucoma, surgery, Ahmed valve
Patients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction.
Procedure: Ahmed valve
The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure reduction
Time Frame: 4 years
The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
development of visual acuity
Time Frame: 4 years
The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years.
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of glaucoma medication
Time Frame: 4 years
The number of glaucoma medication after Ahmed glaucoma valve implantation are being examined over a period of 4 years.
4 years
postoperative complications
Time Frame: 4 years
Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years.
4 years
need for revision operation
Time Frame: 4 years
The need for revision operations after Ahmed glaucoma valve implantation is being examined over a period of 4 years.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Karin R Pillunat, MD, University Dresden, Eye Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahmed-LTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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