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Effectiveness of a Procedure for Previously Failed Glaucoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00347789
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
PharmaLogic Development, Inc.
Information provided by:
Glaucoma Research & Education Group

Brief Summary:
Transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to treat cases with a previously failed trabeculectomy. We will investigate approximately 100 consecutive cases with follow up of up to 9 years. We anticipate that this procedure is an effective, safe, and appropriate option for successful glaucoma treatment.

Condition or disease Intervention/treatment
Glaucoma Procedure: Glaucoma surgery- Bleb revision

Detailed Description:

The healing process after filtering surgery for glaucoma may cause an unsuccessful outcome for the trabeculectomy procedure. In order to control the rising intraocular pressure due to the failed trabeculectomy, medications may be restarted and/or filtering surgery may need to be repeated. Our primary research showed that transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to control this situation.

This retrospective study will follow over 100 patients from May 1997 to May 2006. This long-term follow up will help assess the future role of this technique in glaucoma practices.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Efficacy of Transconjunctival Mitomycin-C in Needle Revisions of Failing Trabeculectomy
Study Start Date : May 1997
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of glaucoma
  • Failed filtering procedures- defined as intraocular pressure exceeded target pressure thus inducing possible further optic nerve damage

Exclusion Criteria:

- Needling combined with other ocular surgical or laser treatments

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): NCT00347789

United States, California
Glaucoma Center of San Francisco
San Francisco, California, United States, 94105
Sponsors and Collaborators
Glaucoma Research & Education Group
PharmaLogic Development, Inc.
Principal Investigator: Andrew G. Iwach, MD Glaucoma Reseach & Education Group

ClinicalTrials.gov Identifier: NCT00347789     History of Changes
Other Study ID Numbers: 11111
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by Glaucoma Research & Education Group:
filtering bleb revision
intraocular pressure
needling procedure
mitomycin C

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors