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The study will evaluate the efficacy and safety of MINIject 636 and 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 efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINIject DO Integrated System CS636 (MINI DO636) | Experimental | MINIject 636 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. In this arm the implant is placed using Dual Operator Delivery Tool (DODT). |
|
| MINIject SO Integrated System CS636 (MINI SO636) | Experimental | MINIject 636 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. In this arm the implant is placed using Single Operator Delivery Tool (SODT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINI DO636 | Device | MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in medicated diurnal IOP | DODT/SODT arm will be evaluated separately | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubair Hussain, PhD | iSTAR Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Oftalmológica del Caribe | Barranquilla | Colombia | ||||
| Maxivision Eye Hospital |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm
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|
| MINI SO636 | Device | MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636). |
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| Hyderabad |
| Telangana |
| 500034 |
| India |
| Panama Eye Center | Panama City | Panama |