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

January 11, 2018 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.
Drug: Mitomycin-C
Procedure: Placement of the sponge
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post-operative day 1 to month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post-operative day 1 to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Leon Herndon, MD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

January 17, 2017

Study Completion (ACTUAL)

January 17, 2017

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (ESTIMATE)

December 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00048136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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