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A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy (Optonol)
This study is currently recruiting participants.
Verified by Indiana University, August 2008
Sponsors and Collaborators: Indiana University
Optonol
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00597181
  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 IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
Drug Information available for: Mitomycin Mitomycins
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma

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
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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
2: Active Comparator
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

Contacts
Contact: Joni S Hoop, CCRC 317-274-2745 jhoop@iupui.edu
Contact: Linda S Morgan, CCRC 317-274-2745 lismorga@iupui.edu

Locations
United States, Indiana
IU Eye at Carmel Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Joni S Hoop, CCRC     317-274-2745     jhoop@iupui.edu    
Contact: Linda S Morgan, CCRC     317-274-2745     lismorga@iupui.edu    
Principal Investigator: Louis B Cantor, MD            
Sub-Investigator: Darrell WuDunn, MD, PhD            
Sub-Investigator: Yara P Catoira-Boyle, MD            
Sponsors and Collaborators
Indiana University
Optonol
Investigators
Principal Investigator: Louis B Cantor, MD Indiana University School of Medicine
  More Information

Publications:
Responsible Party: Indiana University ( Louis B. Cantor, M.D. )
Study ID Numbers: 0710-28
Study First Received: January 7, 2008
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00597181  
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Inflammatory response

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Mitomycin
Mitomycins
Hypertension
Ocular Hypertension

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

ClinicalTrials.gov processed this record on January 16, 2009