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The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goniotomy | Experimental | Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant. |
|
| Trabecular Micro-Bypass Stent | Active Comparator | Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goniotomy | Procedure | Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in mean IOP | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luana Wilbur, BS | Pilot to Pivotal Consulting, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 4, 2021 | |
| Reset | Dec 1, 2021 | |
| Release | Apr 11, 2022 | |
| Reset | May 6, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 4, 2021 | Dec 1, 2021 | |||
| Apr 11, 2022 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D054140 | Refractive Surgical Procedures |
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| Trabecular Micro-Bypass Stent | Device | Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant. |
|
| Cataract Extraction | Procedure | Cataract extraction via Phaco and PCIOL implant. |
|
| May 6, 2022 |