Effectiveness of a Procedure for Previously Failed Glaucoma Surgery

June 30, 2006 updated by: Glaucoma Research & Education Group

Efficacy of Transconjunctival Mitomycin-C in Needle Revisions of Failing Trabeculectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

100

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

  • United States
    • California
      • San Francisco, California, United States, 94105
        • Glaucoma Center of San Francisco

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

Collaborators and Investigators

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

Sponsor

Glaucoma Research & Education Group

Collaborators

PharmaLogic Development, Inc.

Investigators

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

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

May 1, 1997

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

June 30, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11111 (DAIDS ES Registry Number)

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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