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

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ClinicalTrials.gov Identifier: NCT02016898
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Procedure: Placement of the sponge Drug: Mitomycin-C Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
Study Start Date : March 2014
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sponge placement of 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.
 Procedure: Placement of the sponge
Drug: Mitomycin-C
Experimental: Irrigation placement of 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.
 Drug: Mitomycin-C


Outcome Measures
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Primary Outcome Measures :
  1. Complication Rates [ Time Frame: 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 :
  1. Change in Intraocular Pressure [ Time Frame: post-operative day 1 to month 6 ]
    To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016898


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Leon Herndon, MD Duke Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02016898    
Other Study ID Numbers: Pro00048136
First Posted: December 20, 2013    Key Record Dates
Results First Posted: February 9, 2018
Last Update Posted: February 9, 2018
Last Verified: January 2018
Keywords provided by Duke University:
Primary open angle glaucoma
trabeculectomy
mitomycin-C
express mini-shunt
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
 Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors