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

Primary Purpose

Glaucoma

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Trabeculectomy with mitomycin c

Ex-Press mini shunt with mitomycin c

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Inflammatory response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects must:

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

Exclusion Criteria:

No subject may:

Have any contraindication to intraocular surgery.
Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
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.
Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
Require use of ocular NSAID or systemic steroids.
Have known allergy or sensitivity to mitomycin C
Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
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).
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.

Sites / Locations

IU Eye at Carmel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes

Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes

Outcomes

Primary Outcome Measures

Aqueous humor flare

Secondary Outcome Measures

Aqueous humor cell

Full Information

NCT ID

NCT00597181

First Posted

January 7, 2008

Last Updated

September 16, 2010

Sponsor

Indiana University

Collaborators

Optonol

1. Study Identification

Unique Protocol Identification Number

NCT00597181

Brief Title

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

Acronym

Optonol

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 Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Terminated

Why Stopped

Patient population limited

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Indiana University

Collaborators

Optonol

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Inflammatory response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes

Arm Title

Arm Type

Active Comparator

Arm Description

Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes

Intervention Type

Procedure

Intervention Name(s)

Trabeculectomy with mitomycin c

Intervention Description

mitomycin c 0.2 mg/cc for 2 minutes

Intervention Type

Procedure

Intervention Name(s)

Ex-Press mini shunt with mitomycin c

Intervention Description

mitomycin c 0.2 mg/cc for 2 minutes

Primary Outcome Measure Information:

Title

Aqueous humor flare

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Aqueous humor cell

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All subjects must: Be willing and able to provide written Informed Consent. Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. Have medically uncontrolled glaucoma for which they have elected to undergo surgery. Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma. Exclusion Criteria: No subject may: Have any contraindication to intraocular surgery. Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma. 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. Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months. Require use of ocular NSAID or systemic steroids. Have known allergy or sensitivity to mitomycin C Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis B Cantor, MD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

IU Eye at Carmel

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11220271

Citation

Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German.

Results Reference

background

PubMed Identifier

17224744

Citation

Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16(1):14-9. doi: 10.1097/01.ijg.0000243479.90403.cd.

Results Reference

background

PubMed Identifier

8407220

Citation

Shah SM, Spalton DJ, Allen RJ, Smith SE. A comparison of the laser flare cell meter and fluorophotometry in assessment of the blood-aqueous barrier. Invest Ophthalmol Vis Sci. 1993 Oct;34(11):3124-30.

Results Reference

background

PubMed Identifier

15741808

Citation

Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005 Apr;14(2):98-102. doi: 10.1097/01.ijg.0000151688.34904.b7.

Results Reference

background

Citation

Shields, MB Textbook of Glaucoma. Fourth Edition; Williams & Wilkins, Baltimore, 1998.

Results Reference

background

Citation

Guyer DR, Yannuzzi LA, Chang S, Shields JA, Green WR Retina-Vitreous-Macula. W.B. Saunders Company, Philadelphia, 1999.

Results Reference

background

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

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