Phase 2
Completed N=95
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
Source: ClinicalTrials.gov NCT02016898 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Complication Rates — 29; 28 Participants — p=0.7
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Rates |
29; 28 | 0.7 |
| SECONDARY Change in Intraocular Pressure |
-8.4; -8.2 | 0.539 |
Eligibility Criteria
Inclusion Criteria
- Men or women aged 18 years and older at screening.
- Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.
- 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.
- Capable and willing to provide consent
Exclusion Criteria
- Unable or unwilling to provide consent
- 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
- Any previous glaucoma drainage devices in the study eye
- Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.
- Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
- Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
- Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Known Pregnancy or Breastfeeding
Physical and Laboratory Findings
- Conjunctival scarring precluding a superonasal implantation location.
- Vitreous in the anterior chamber.
- Abnormality preventing reliable applanation tonometry in the study eye.
Data sourced from ClinicalTrials.gov (NCT02016898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.