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kerasys had more erosions than tutoplast
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| Name | Class |
|---|---|
| IOP Ophthalmics | UNKNOWN |
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The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KeraSys Tissue Patch Graft | Active Comparator | 20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft |
|
| Tutoplast tissue patch graft | Active Comparator | 20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molteno 3 glaucoma drainage shunt | Procedure | Patients needing glaucoma drainage surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kerasys safety | The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction. | one day, week one, 1 month, 3 month, 6 month, and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery | The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos. | 1 month, 3 month, 6 month, 1 year |
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Inclusion Criteria:
Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene M Moster, MD | Wills Eye Institute Glaucoma Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18303385 | Background | Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D015812 | Glaucoma, Angle-Closure |
| D017889 | Exfoliation Syndrome |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| C000597419 | Tutoplast |
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