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| Name | Class |
|---|---|
| Glaukos Corporation | INDUSTRY |
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The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery for patients with medically uncontrolled POAG | Experimental | surgery using combined minimally invasive surgical iStent infinite trabecular micro-bypass systme model iS3 and drug depot iDose TR (Travoprost Intracameral Implant) 75mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent infinite trabecular micro-bypass system model iS3 | Device | surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP reduction from baseline | a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables. | Diurnal IOP reduction from baseline at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meskerem Divers | Contact | 215-825-4712 | mdivers@willseye.org | |
| Jeanne L Molineaux, COA | Contact | 215-825-4713 | jmolineaux@willseye.org |
| Name | Affiliation | Role |
|---|---|---|
| Dilru Amarasekera, MD | Wills Eye Hospital Glaucoma Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hosital Glaucoma Dept. | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
The study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data will be kept on file at Wills Eye Hospital for 7 years. Researchers can request this data by email to glaucoma@willseye.org with a description of their planned use.
This is a 5 year study with anticipated completion of enrollment and data December 2031.
Researchers can request the study protocol, Statistical Analysis Plan (SAP), informed Consent Form, and deidentified participant and group data with a description of their planned use
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Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg
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| iDose TR (Travoprost intracameral Implant) 75mcg | Drug | surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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