A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy (Optonol)

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. Identifier: NCT00597181
Recruitment Status : Terminated (Patient population limited)
First Posted : January 17, 2008
Last Update Posted : September 17, 2010
Information provided by:
Indiana University

Brief Summary:
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Trabeculectomy with mitomycin c Procedure: Ex-Press mini shunt with mitomycin c Phase 4

Detailed Description:
The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma
Study Start Date : November 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: 1
Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes
Procedure: Trabeculectomy with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes

Active Comparator: 2
Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes
Procedure: Ex-Press mini shunt with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes

Primary Outcome Measures :
  1. Aqueous humor flare [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Aqueous humor cell [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All subjects must:

  1. Be willing and able to provide written Informed Consent.
  2. Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study.
  3. Be male or female of any race at least 18 years of age.
  4. Have medically uncontrolled glaucoma for which they have elected to undergo surgery.
  5. Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma.

Exclusion Criteria:

No subject may:

  1. Have any contraindication to intraocular surgery.
  2. Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
  3. Have any active ocular disease other than glaucoma that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
  4. Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
  5. Require use of ocular NSAID or systemic steroids.
  6. Have known allergy or sensitivity to mitomycin C
  7. Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
  8. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
  9. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
  10. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.

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 identifier (NCT number): NCT00597181

United States, Indiana
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Indiana University
Principal Investigator: Louis B Cantor, MD Indiana University School of Medicine

Responsible Party: Louis B. Cantor, M.D., Indiana University Identifier: NCT00597181     History of Changes
Other Study ID Numbers: 0710-28
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by Indiana University:
Inflammatory response

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