The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Primary Open Angle Glaucoma Clinical Trial

Official title:

The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016898
• Other study ID #: Pro00048136
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2013
• Last updated: January 11, 2018
• Start date: March 2014
• Est. completion date: January 17, 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men or women aged 18 years and older at screening.

2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.

3. Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with MMC in the superonasal quadrant in the study eye which the physician deems as medically necessary.

4. Capable and willing to provide consent

Exclusion Criteria:

1. Unable or unwilling to provide consent

2. Any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the superonasal quadrant

3. Any previous glaucoma drainage devices in the study eye

4. Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.

5. Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.

6. Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.

7. Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

8. Known Pregnancy or Breastfeeding

Physical and Laboratory Findings

9. Conjunctival scarring precluding a superonasal implantation location.

10. Vitreous in the anterior chamber.

11. Abnormality preventing reliable applanation tonometry in the study eye.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Procedure:
• Placement of the sponge

Drug:
• Mitomycin-C

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rates	To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation	post-operative day 1 to month 6
Secondary	Change in Intraocular Pressure	To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation	post-operative day 1 to month 6