Effectiveness of a Procedure for Previously Failed Glaucoma Surgery

Sponsor
Glaucoma Research & Education Group (Other)
Overall Status
Completed
CT.gov ID
NCT00347789
Collaborator
PharmaLogic Development, Inc. (Industry)
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Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Retrospective
Official Title:
Efficacy of Transconjunctival Mitomycin-C in Needle Revisions of Failing Trabeculectomy
Study Start Date :
May 1, 1997
Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glaucoma Center of San Francisco San Francisco California United States 94105

    Sponsors and Collaborators

    • Glaucoma Research & Education Group
    • PharmaLogic Development, Inc.

    Investigators

    • Principal Investigator: Andrew G. Iwach, MD, Glaucoma Reseach & Education Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00347789
    Other Study ID Numbers:
    • 11111
    First Posted:
    Jul 4, 2006
    Last Update Posted:
    Jul 4, 2006
    Last Verified:
    Jun 1, 2006

    Study Results

    No Results Posted as of Jul 4, 2006