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The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stand-alone | Experimental | Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma device implantation in a stand-alone procedure | Device | MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualified success for lowering the IOP | The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and > 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study | show safety of the MINIject implant and the procedure used to implant the device | up to 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Pfeiffer, Prof. | Universitätsklinikum Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center Hospotalier Universitaire Genoble Alpes | Grenoble | 38043 | France | |||
| Hôpital de la Croix Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32769736 | Result | Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632. |
| Label | URL |
|---|---|
| Homepage of the company and information about the product | View source |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
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| Lyon |
| 69004 |
| France |
| Ludwig-Maximilians-University Munich | Munich | Bavaria | 80336 | Germany |
| Uni-Augenklinik Bochum | Bochum | North Rhine-Westphalia | 44892 | Germany |
| Uniklinik Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Hospital Clínico San Carlos | Madrid | Spain |