A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy
NCT ID: NCT00597181
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
40 participants
INTERVENTIONAL
2007-11-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes
Trabeculectomy with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
2
Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes
Ex-Press mini shunt with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
Interventions
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Trabeculectomy with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
Ex-Press mini shunt with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Optonol
UNKNOWN
Indiana University
OTHER
Responsible Party
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Indiana University
Principal Investigators
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Louis B Cantor, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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IU Eye at Carmel
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
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.
Shields, MB Textbook of Glaucoma. Fourth Edition; Williams & Wilkins, Baltimore, 1998.
Guyer DR, Yannuzzi LA, Chang S, Shields JA, Green WR Retina-Vitreous-Macula. W.B. Saunders Company, Philadelphia, 1999.
Other Identifiers
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0710-28
Identifier Type: -
Identifier Source: org_study_id