Long Term Outcome After Ahmed Glaucoma Valve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01741961
First received: November 22, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Glaucoma
Procedure: Ahmed valve

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: 4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • intraocular pressure reduction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.


Secondary Outcome Measures:
  • development of visual acuity [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years.


Other Outcome Measures:
  • reduction of glaucoma medication [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The number of glaucoma medication after Ahmed glaucoma valve implantation are being examined over a period of 4 years.

  • postoperative complications [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years.

  • need for revision operation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The need for revision operations after Ahmed glaucoma valve implantation is being examined over a period of 4 years.


Enrollment: 214
Study Start Date: June 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Patients suffering from medically uncontrolled glaucoma
  • Informed consent

Exclusion Criteria:

  • healthy subjects
  • under 18 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01741961

Locations
Germany
University Eye Clinic Dresden
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Karin R Pillunat, MD University Dresden, Eye Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Karin Pillunat, Principal Investigator, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01741961     History of Changes
Other Study ID Numbers: Ahmed-LTO
Study First Received: November 22, 2012
Last Updated: December 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
uncontrolled glaucoma
glaucoma drainage device

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014