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The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.
The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.
Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS) | Device | The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP | Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications | 6 months |
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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 |
|---|---|---|---|---|---|---|
| Panama Eye Center | Panama City | Panama | ||||
| Hospital ClÃnico San Carlos |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| Madrid |
| Spain |
| East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital | Colchester | Essex | United Kingdom |
| Princess Alexandra Eye Pavilion | Edinburgh | United Kingdom |