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This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device FG300X | Active Comparator | One version of delivery tool |
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| Investigational device FG300Y | Active Comparator | One version of delivery tool |
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| Investigational device FG300Z | Active Comparator | One version of delivery tool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIGS | Device | Implant MINIject S+ in supraciliary space |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader | Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader. | 1 week |
| Ease of use evaluation | Ease of Use, as measured by sponsor review of the surgical procedure and surgeon feedback. | during the surgery procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity from baseline to 6-, 12- and 24-months follow-up | Best corrected visual acuity measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Change from baseline to 6-, 12- and 24-months follow-up will be evaluated. | Baseline, 6, 12, and 24 months |
| Rate of secondary surgical interventions at Month 6, Month 12 and Month 24 |
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Inclusion criteria
Males or females, 20 years of age or older
Diagnosis of open angle glaucoma (OAG) in the study eye
Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
Maximal C/D ratio must be 0.9 in the study eye
Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations
Subjects must provide written informed consent prior to any study procedures
Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:
Exclusion criteria
Subjects are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Hanot Mambres, PhD | Contact | 0032472384955 | delphine.hanot@istar-medical.com | |
| Sabine Glibert | Contact | 0032476609408 | sabine.glibert@istar-medical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Robles Vision d/b/a Centro Oftalmológico Robles | Recruiting | Santa Rosa de Copán | 41101 | Honduras |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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FG300X The distal extremity features a closed, blunt tip that opens via a hinge positioned on the upper side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%.
FG300Y The distal extremity features a closed, blunt tip that opens via a hinge positioned on the bottom side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.25 N +/- 0.06 N. The curvature slope is defined as 1-20%.
FG300Z The distal extremity features an open, blunt tip without hinge. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%.
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Cumulative rate of secondary surgical interventions due to the glaucoma device or related to glaucoma surgical procedure at Month 6, Month 12 and Month 24. |
| 6, 12, and 24 months |
| Change in Endothelial Cell Density from baseline to 6-, 12- and 24-months follow-up | Change from baseline in endothelial cell density (ECD), measured at Month 6, Month 12, and Month 24. | Baseline, 6, 12 and 24 months |
| Cumulative Rate of Adverse Events at 6, 12 and 24 months. | Cumulative rate of adverse events (AEs), adverse device effects (ADEs), and adverse events of special interest (AESIs) at 6-, 12- and 24-months follow-up. | 6, 12 and 24 months |
| Proportion of eyes achieving ≥20% reduction in diurnal IOP from baseline to 6-, 12- and 24-months follow-up | Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, and from baseline to 12- and 24-months follow-up, with or without IOP lowering medications. | Baseline, 6, 12, 24 months |
| 'Qualified success' rate from baseline to 6-, 12- and 24-months follow-up | 'Qualified success' rate at 6-, 12- and 24-month follow-up. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline at a given follow-up visit. | 6, 12 and 24 months |
| 'Complete success' rate from baseline to 6-, 12- and 24-months follow-up | 'Complete success' rate at 6-, 12- and 24-months follow-up. 'Complete success' is defined as diurnal IOP ≤ 21mmHg and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline without the need for any IOP-lowering medication at the given follow-up visit. | 6, 12 and 24 months |
| Change in diurnal IOP from baseline to 6-, 12- and 24-months follow-up | Change (absolute and relative) in diurnal IOP from baseline visit to 6-, 12- and 24-months follow-up. | Baseline, 6, 12 and 24 months |
| Change in number of IOP-lowering medication from baseline to 6-, 12- and 24-months follow-up. | Change (absolute and relative) in number of IOP-lowering medications from baseline to 6-, 12- and 24-months follow-up. | Baseline, 6, 12 and 24-months |
| Colchester General Hospital | Recruiting | Colchester | CO45JL | United Kingdom |
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| Diana, Princess of Wales Hospital | Recruiting | Grimsby | DN33 2 | United Kingdom |
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| Royal Liverpool University Hospital | Recruiting | Liverpool | L7 3 | United Kingdom |
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| St Thomas' Hospital | Recruiting | London | SE17EH | United Kingdom |
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