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

Duke University

Status and phase: Completed; Phase 2

Conditions: Primary Open Angle Glaucoma

Treatments: Procedure: Placement of the sponge; Drug: Mitomycin-C

Study type: Interventional

Funder types: Other

Identifiers

NCT02016898

Pro00048136

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Sponge placement of Mitomycin-C

Experimental group

Description:

Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.

Treatment:

Drug: Mitomycin-C

Procedure: Placement of the sponge

Irrigation placement of Mitomycin-C

Experimental group

Description:

Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.

Treatment:

Drug: Mitomycin-C