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Evaluate the safety and effectiveness of iSTAR Medical's MINIjectâ„¢ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIjectâ„¢ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINIjectâ„¢ Implant | Device | The MINIjectâ„¢ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIjectâ„¢ SO627 and the SO Delivery System, designed to deliver the MINIjectâ„¢ implant into the supraciliary space. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure decrease | Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24. | 24 months |
| Intraocular pressure decrease (outcome 2) | Change from baseline in mean unmedicated diurnal IOP at Month 24. | 24 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Glibert | iSTAR Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advanced Eye Research Institute | Glendale | Arizona | 85306 | United States | ||
| Vold Vision |
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Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.
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|
| Fayetteville |
| Arkansas |
| 72704 |
| United States |
| Beverly Hills Institute of Ophthalmology | Beverly Hills | California | 90210 | United States |
| Reeve Woods Eye Center | Chico | California | 95926 | United States |
| Sacramento Eye Consultants, A Medical Corporation | Sacramento | California | 95815 | United States |
| Grand Junction Eye Care | Grand Junction | Colorado | 81501 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Intermountain Eye Center | Eagle | Idaho | 83616 | United States |
| Illinois Eye Center | Peoria | Illinois | 61615 | United States |
| Virdi Eye Clinic | Rock Island | Illinois | 61201 | United States |
| Stiles Eyecare Excellene and Glaucoma Institute | Overland Park | Kansas | 66213 | United States |
| LA Eye and Laser | Alexandria | Louisiana | 71303 | United States |
| Minnesota Eye Consultants | Bloomington | Minnesota | 55431 | United States |
| Eye Consultants PC | Omaha | Nebraska | 68124 | United States |
| Center for Sight Las Vegas | Las Vegas | Nevada | 89145 | United States |
| NYU Langone Ophthalmology | New York | New York | 10017 | United States |
| Apex Eye Clinical Research, LLC | Mason | Ohio | 45040 | United States |
| Oklahoma Eye Surgeons | Oklahoma City | Oklahoma | 73112 | United States |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79922 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
| R and R Eye Research | San Antonio | Texas | 78229 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| Eye Centers of Racine and Kenosha | Kenosha | Wisconsin | 53142 | United States |
| Prism Eye Institute | Oakville | Ontario | L6H 0J8 | Canada |
| The Institute de l'Oeil des Laurentides | Boisbriand | Quebec | J7N0C2 | Canada |
| Clinique Opthalmologies Bellevue | Montreal | Canada |
| Swiss Glaucoma Research Foundation Swiss Visio Montchoisi | Lausanne | Switzerland |
| Queen Victoria Hospital NHS Foundation Trust | East Grinstead | United Kingdom |
| Glaucoma Service Moorfields Eye Hospital | London | United Kingdom |
| Imperial College Healthcare NHS Trust Western Eye Hospital | London | United Kingdom |
| KCL Frost Eye Research Department St Thomas' Hospital | London | United Kingdom |
| Research & Development Unit, Learning and Research Centre (LaRC), York Hospital | York | United Kingdom |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D000080324 | Choroidal Effusions |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D005124 | Eye Abnormalities |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
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