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

Phase 4

Terminated

• Conditions: Glaucoma
• Interventions: Procedure: Trabeculectomy with mitomycin c; Procedure: Ex-Press mini shunt with mitomycin c

• Registration Number: NCT00597181
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Primary Completion: 2009-01
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Trabeculectomy with mitomycin c	Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes
2	Ex-Press mini shunt with mitomycin c	Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes

Primary Outcome Measures

Name	Time	Method
Aqueous humor flare	2 months

Secondary Outcome Measures

Name	Time	Method
Aqueous humor cell	2 months

Trial Locations

Locations (1)

IU Eye at Carmel; 🇺🇸 Indianapolis, Indiana, United States