Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Shunt Tube Exposure Prevention Study (STEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Glaucoma
Interventions Procedure: GDD
Procedure: Amniotic Membrane Graft
Procedure: Pericardial Graft
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Hide Arm/Group Description

After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.

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.

Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.

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.

Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

Period Title: Overall Study
Started 41 41
Completed 41 40
Not Completed 0 1
Arm/Group Title GDD & Amniotic Membrane Graft GDD & Pericardial Graft Total
Hide Arm/Group Description

After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.

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.

Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.

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.

Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Yrs
Number Analyzed 41 participants 40 participants 81 participants
65.4  (13.6) 68.9  (12.3) 67  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
22
  53.7%
28
  70.0%
50
  61.7%
Male
19
  46.3%
12
  30.0%
31
  38.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
4
  10.0%
4
   4.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  43.9%
10
  25.0%
28
  34.6%
White
23
  56.1%
26
  65.0%
49
  60.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Tube Exposure
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Hide Arm/Group Description:

After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.

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.

Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.

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.

Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

Overall Number of Participants Analyzed 41 40
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.9%
11
  27.5%
2.Secondary Outcome
Title GDD Failure
Hide Description 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.
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Hide Arm/Group Description

After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.

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.

Amniotic Membrane Graft: For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.

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.

Pericardial Graft: For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

All-Cause Mortality
GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GDD & Amniotic Membrane Graft GDD & Pericardial Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)   3/41 (7.32%) 
Eye disorders     
Corneal Edema *  2/41 (4.88%)  3/41 (7.32%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs
Organization: TissueTech
Phone: (888) 296-8858
EMail: info@tissuetech.com
Layout table for additonal information
Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT01551550    
Other Study ID Numbers: P010-2, Version 4
R44EY019785 ( U.S. NIH Grant/Contract )
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: August 22, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019