Glaucoma
Conditions
Keywords
Inflammatory response
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.
Interventions
PROCEDURETrabeculectomy with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
PROCEDUREEx-Press mini shunt with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
Sponsors
Optonol
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aqueous humor flare | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Aqueous humor cell | 2 months |
Countries
United States
Outcome results
None listed