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

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Procedure: Placement of the sponge; Drug: Mitomycin-C

• Registration Number: NCT02016898
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Study Start: 2014-03
• Primary Completion: 2017-01-17
• Study Completion: 2017-01-17
• Status Verified: 2018-01
• Results First Submitted: 2018-01-11
• Results First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Results First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sponge placement of Mitomycin-C	Placement of the sponge	Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Sponge placement of Mitomycin-C	Mitomycin-C	Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement of Mitomycin-C	Mitomycin-C	Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.

Primary Outcome Measures

Name	Time	Method
Complication Rates	post-operative day 1 to month 6	To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation

Secondary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure	post-operative day 1 to month 6	To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States