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

This study has been terminated.
(Patient population limited)
Sponsor:
Collaborator:
Optonol
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00597181
First received: January 7, 2008
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
Drug Information available for: Mitomycin
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Aqueous humor flare [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aqueous humor cell [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597181

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

Publications:

Responsible Party: Louis B. Cantor, M.D., Indiana University
ClinicalTrials.gov Identifier: NCT00597181     History of Changes
Other Study ID Numbers: 0710-28
Study First Received: January 7, 2008
Last Updated: September 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Inflammatory response

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

ClinicalTrials.gov processed this record on May 23, 2013