N/A
Completed N=82
Shunt Tube Exposure Prevention Study
Source: ClinicalTrials.gov NCT01551550 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Tube Erosion — 2; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tube Erosion |
2; 11 | — |
| SECONDARY Number of Participants With Glaucoma Drainage Device Failure |
2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT01551550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.