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Shunt Tube Exposure Prevention Study (STEPS)

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ClinicalTrials.gov Identifier: NCT01551550
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
National Eye Institute (NEI)
Bascom Palmer Eye Institute
The New York Eye & Ear Infirmary
Columbia University
Information provided by (Responsible Party):
Tissue Tech Inc.

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 12, 2012
Results First Submitted Date  ICMJE August 22, 2019
Results First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
Tube Exposure [ Time Frame: 2 years ]
Impending conjunctival erosion can be indicated by loss of conjunctival capillaries over the tube, usually 1 to 3 mm from the corneoscleral junction. Definitive tube exposure is accompanied by conjunctival tissue loss, graft melting.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
Tube Exposure [ Time Frame: 2 years ]
Impending conjunctival erosion can be indicated by loss of conjunctival capillaries over the tube, usually 1 to 3 mm from the corneoscleral junction. Diffinitive tube exposure is accompanied by conjunctival tissue loss, graft melting.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
GDD Failure [ Time Frame: 2 years ]
GDD Failure, based on reoperation to control the IOP, and also include the defined by the following criteria: (1) IOP ≥21 mm Hg or not reduced by 30% below baseline on two consecutive follow-up visits after 3 months. (2) IOP ≤5 mm Hg on two consecutive follow-up visits after 3 months. (3) Additional glaucoma surgery. (4) Loss of light perception vision.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shunt Tube Exposure Prevention Study
Official Title  ICMJE Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial
Brief Summary This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt tube exposure in patients undergoing glaucoma drainage device implantation.
Detailed Description

Glaucoma drainage devices (GDDs) have been used in the treatment of high-risk refractory glaucoma. To avoid tube exposure, which may lead to serious eye infection, the implanted GDD tube must be covered by a patch graft, traditionally made of either donor sclera or pericardium. However, these patch grafts still carry a high rate of progressive thinning and erosion, a complication that the investigators speculate results from the lack of cellular infiltration from the surrounding host conjunctival stroma and poor integration of these patch grafts to the host tissue. The investigators further speculate that a thicker version of cryo-preserved amniotic membrane (AM), manufactured by Bio-Tissue, Inc.,could offer better tensile strength, be suitable for tectonic support, and have biological activities to promote cellular infiltration by the surrounding host conjunctival stroma, thus reducing progressive allogeneic patch graft thinning/erosion.

Through SBIR Phase I grant support (R43 EY19785), the investigators have evaluated the thicker AM as an alternative patch graft for covering the GDD tube during the primary implantation. The investigators further monitored the host cell interaction using anterior segment optical coherence tomography (OCT). The investigators have successfully accomplished the proposed aims of the above studies, which demonstrated the short-term stability/efficacy of AM in covering the tube in primary GDD surgery (Phase I-Aim 1) and confirmed the feasibility of using OCT to distinguish host cell infiltration into the AM after transplantation over the GDD tube (Phase I-Aim 2).

In this SBIR Phase II, the investigators propose to conduct a prospective, controlled study to compare the long-term safety and efficacy of the thicker AM (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) to the pericardium (Tutoplast®, IOP Inc, Costa Mesa, CA) in securing the GDD tube and reducing tube exposure and graft thinning in patients with high risk glaucoma. The investigators will also study the risk factors that may contribute to GDD tube exposure.

Accomplishment of this Phase II study will position AM as an effective alternative to the existing patch grafts to reduce tube exposure and enhance the success of GDD implantation, while providing a better aesthetic appearance and allowing visualization of the tube in patients with high risk glaucoma. The investigators speculate that such a graft might also have other clinical applications outside of covering GDD tubes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Procedure: GDD
    The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.
    Other Names:
    • Glaucoma drainage device
    • Tube shunt
    • Shunt tube
    • Ahmed Valve
    • Baerveldt valve
  • Procedure: Amniotic Membrane Graft
    For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
    Other Name: Amnioguard
  • Procedure: Pericardial Graft
    For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
    Other Name: Tutoplast
Study Arms  ICMJE
  • Experimental: GDD & Amniotic Membrane Graft
    After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.
    Interventions:
    • Procedure: GDD
    • Procedure: Amniotic Membrane Graft
  • Active Comparator: GDD & Pericardial Graft
    After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.
    Interventions:
    • Procedure: GDD
    • Procedure: Pericardial Graft
Publications * Anand A, Sheha H, Teng CC, Liebmann JM, Ritch R, Tello C. Use of amniotic membrane graft in glaucoma shunt surgery. Ophthalmic Surg Lasers Imaging. 2011 May-Jun;42(3):184-9. doi: 10.3928/15428877-20110426-01.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
82
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2012)
96
Actual Study Completion Date  ICMJE August 3, 2019
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:

    1. Primary open angle glaucoma with previous conjunctival cutting surgery including prior failed trabeculectomy.
    2. Secondary glaucoma, e.g., neovascular, uveitic, or post-traumatic glaucoma.
  • Age range: 21- 80 years old.
  • Both genders and all ethnic groups comparable with the local community.
  • Patients able and willing to cooperate with investigational plan.
  • Patients able and willing to complete postoperative follow-up.
  • Patients able to understand and willing to sign a written informed consent.

Exclusion Criteria:

  • Ocular infection within 14 days prior to prior to study entry.
  • No light perception vision
  • Previous cyclodestructive procedure.
  • Children under 21 (see Inclusion of Children).
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551550
Other Study ID Numbers  ICMJE P010-2, Version 4
R44EY019785 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tissue Tech Inc.
Study Sponsor  ICMJE Tissue Tech Inc.
Collaborators  ICMJE
  • National Eye Institute (NEI)
  • Bascom Palmer Eye Institute
  • The New York Eye & Ear Infirmary
  • Columbia University
Investigators  ICMJE
Principal Investigator: Hosam El Sheha, MD, PhD Tissue Tech Inc.
PRS Account Tissue Tech Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP