Trial Outcomes & Findings for Shunt Tube Exposure Prevention Study (NCT NCT01551550)
NCT ID: NCT01551550
Last Updated: 2022-05-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
2 years
Results posted on
2022-05-18
Participant Flow
Participant milestones
| Measure |
GDD & Amniotic Membrane Graft
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.
|
GDD & Pericardial Graft
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 Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shunt Tube Exposure Prevention Study
Baseline characteristics by cohort
| Measure |
GDD & Amniotic Membrane Graft
n=41 Participants
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.
|
GDD & Pericardial Graft
n=40 Participants
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
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 yrs
STANDARD_DEVIATION 13.6 • n=5 Participants
|
68.9 yrs
STANDARD_DEVIATION 12.3 • n=7 Participants
|
67 yrs
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsImpending 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.
Outcome measures
| Measure |
GDD & Amniotic Membrane Graft
n=41 Participants
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.
|
GDD & Pericardial Graft
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With Tube Erosion
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 yearsGDD 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.
Outcome measures
| Measure |
GDD & Amniotic Membrane Graft
n=41 Participants
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.
|
GDD & Pericardial Graft
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With Glaucoma Drainage Device Failure
|
2 Participants
|
2 Participants
|
Adverse Events
GDD & Amniotic Membrane Graft
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GDD & Pericardial Graft
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GDD & Amniotic Membrane Graft
n=41 participants at risk
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.
|
GDD & Pericardial Graft
n=41 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Corneal Edema
|
4.9%
2/41
|
7.3%
3/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place