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

Glaucoma Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00597181
• Other study ID #: 0710-28
• Status: Terminated
• Phase: Phase 4
• First received: January 7, 2008
• Last updated: September 16, 2010
• Start date: November 2007
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	IU Eye at Carmel	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Optonol

Country where clinical trial is conducted

United States, 

References & Publications (6)

Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005 Apr;14(2):98-102. — View Citation

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

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. German. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aqueous humor flare		2 months	No
Secondary	Aqueous humor cell		2 months	No