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

September 16, 2010 updated by: Indiana University

A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Phase 4

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
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • IU Eye at Carmel

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aqueous humor flare
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Aqueous humor cell
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

Optonol

Investigators

  • Principal Investigator: Louis B Cantor, MD, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0710-28

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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