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

NCT00597181 | Terminated Phase 4

• 1 other identifier: 0710-28
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Inflammatory response

Outcome Measures

Primary Outcomes (1)

• Aqueous humor flare

  2 months

Secondary Outcomes (1)

• Aqueous humor cell

  2 months

Study Arms (2)

1

ACTIVE COMPARATOR

Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes

Procedure: Trabeculectomy with mitomycin c

2

ACTIVE COMPARATOR

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

Procedure: Ex-Press mini shunt with mitomycin c

Interventions

Trabeculectomy with mitomycin c PROCEDURE

mitomycin c 0.2 mg/cc for 2 minutes

1

Ex-Press mini shunt with mitomycin c PROCEDURE

mitomycin c 0.2 mg/cc for 2 minutes

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Optonol: collaborator

Study Sites (1)

IU Eye at Carmel

Indianapolis, Indiana, 46290, United States

Location

Related Publications (6)

• 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.

  PMID: 11220271 BACKGROUND

• 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.

  PMID: 17224744 BACKGROUND

• 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.

  PMID: 8407220 BACKGROUND

• 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.

  PMID: 15741808 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy; Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Louis B Cantor, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 17, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2010
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

US (1)