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| Name | Class |
|---|---|
| American Glaucoma Society | OTHER |
| University of Pittsburgh | OTHER |
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The aim of this study is to assess whether delaying early flow through the Ahmed tube shunt may improve the post-operative surgical outcomes and provide a more predictable outcome. To assess this the investigator will conduct a, randomized prospective, multi-centered study with collaborators at WashU in St. Louis, Duke University, Indiana University and the University of Pittsburgh. Participants will be randomized to have an AGV placement with tube ligation (no-early flow) and without ligation (allowing for early flow). IOP will be measured at day one, week one, and months, one, three six, and twelve. Additionally, clinical data regarding number of glaucoma medications, and complications post-operative complications will also be collected.
The purpose of this study is to compare the post-operative surgical outcomes and complication rates in patients with different surgical techniques in the Ahmed FP7 glaucoma valve implant (New World Medical, Inc., Rancho Cucamonga, CA). In particular, the investigator wishes to assess whether delaying early aqueous flow by using a vicryl ligature (as done in most non-valved glaucoma drainage device implantation) will reduce the hypertensive phase, reduce early encapsulation, and optimize healing dynamics to allow for improved long term IOP results compared to standard implantation techniques.
Aggressive early aqueous flow may introduce inflammatory mediators that may increase fibrosis during wound healing. Furthermore, mechanical compression of the tissue surrounding the plate may further lead to a denser capsule and limit aqueous diffusion through Tenon's and conjunctiva. For these reasons, the investigator postulate's that the limitation of early aqueous flow through the Ahmed valve will reduce the rates of hypertensive phase, lead to a thinner and less encapsulated bleb, reduce complication rates such as hypotony, and lead to overall improvement in long-term IOP reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Implantation | Standard Implantation |
| |
| Tied off Tube | Tied off Tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Implantation | Procedure | Traditional Ahmed plantation without vicryl ligature |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP Change | Change IOP | Months 1, 3 , 6, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Change | Change glaucoma medications | Months 1, 3, 6, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Change Hypotony, Reoperations, Significant Vision Loss | Months 1, 3, 6, and 12 |
| Surgical Case Time | Decrease surgical case time |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include patients where the clinical and surgical decision is to undergo an Ahmed glaucoma valve implantation. Participants will be identified by the ophthalmologist overseeing their glaucoma care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amer Al Badwai | Contact | 314-286-2946 | aamer@wustl.edu | |
| Eve Adcock | Contact | 314-273-3557 | adcockl@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| James Liu, MD | Washington University St. Louis MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | Recruiting | St Louis | Missouri | 63108 | United States |
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| Tied off Tube | Procedure | Ahmed implantation with vicryl ligature |
|
| Post op day 0 |
| Capsule Thickness as measured by anterior segment OCT | Capsule Thickness as measured by anterior segment OCT | month 6 |