Effectiveness of a Procedure for Previously Failed Glaucoma Surgery

This study has been completed.
Sponsor:
Collaborator:
PharmaLogic Development, Inc.
Information provided by:
Glaucoma Research & Education Group
ClinicalTrials.gov Identifier:
NCT00347789
First received: June 30, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 Intervention
Glaucoma
Procedure: Glaucoma surgery- Bleb revision

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Efficacy of Transconjunctival Mitomycin-C in Needle Revisions of Failing Trabeculectomy

Resource links provided by NLM:


Further study details as provided by Glaucoma Research & Education Group:

Estimated Enrollment: 100
Study Start Date: May 1997
Estimated Study Completion Date: June 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347789

Locations
United States, California
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347789     History of Changes
Other Study ID Numbers: 11111
Study First Received: June 30, 2006
Last Updated: June 30, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 18, 2014