Shunt Tube Exposure Prevention Study
STEPS
Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial
2 other identifiers
interventional
82
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2019
CompletedResults Posted
Study results publicly available
September 11, 2019
CompletedMay 18, 2022
April 1, 2022
3.5 years
March 8, 2012
August 22, 2019
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Tube Erosion
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.
2 years
Secondary Outcomes (1)
Number of Participants With Glaucoma Drainage Device Failure
2 years
Study Arms (2)
GDD & Amniotic Membrane Graft
EXPERIMENTALAfter GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.
GDD & Pericardial Graft
ACTIVE COMPARATORAfter GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.
Interventions
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.
For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
Eligibility Criteria
You may qualify if:
- Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:
- Primary open angle glaucoma with previous conjunctival cutting surgery including prior failed trabeculectomy.
- 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.
You may not qualify if:
- Ocular infection within 14 days prior to prior to study entry.
- No light perception vision
- Previous cyclodestructive procedure.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioTissue Holdings, Inclead
- National Eye Institute (NEI)collaborator
- Bascom Palmer Eye Institutecollaborator
- The New York Eye & Ear Infirmarycollaborator
- Columbia Universitycollaborator
Study Sites (4)
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Manhattan Eye, Ear, and Throat Hospital
New York, New York, 10021, United States
Harkness Eye Institute/ Columbia University
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 21563743RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Affairs
- Organization
- TissueTech
Study Officials
- PRINCIPAL INVESTIGATOR
Hosam El Sheha, MD, PhD
BioTissue Holdings, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
June 1, 2013
Primary Completion
December 1, 2016
Study Completion
August 3, 2019
Last Updated
May 18, 2022
Results First Posted
September 11, 2019
Record last verified: 2022-04