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Long Term Outcome After Ahmed Glaucoma Valve

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ClinicalTrials.gov Identifier: NCT01741961
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

Condition or disease Intervention/treatment
Glaucoma Procedure: Ahmed valve

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 Design

Study Type : Observational
Actual Enrollment : 214 participants
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
Study Start Date : June 2006
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. postoperative complications [ Time Frame: 4 years ]
    Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Dr. Karin Pillunat, Principal Investigator, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01741961     History of Changes
Other Study ID Numbers: Ahmed-LTO
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Dr. Karin Pillunat, Dresden University of Technology:
uncontrolled glaucoma
glaucoma drainage device

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases