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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Implant MINIject S+ in supraciliary space
Los Robles Vision d/b/a Centro Oftalmológico Robles
Santa Rosa de Copán, Honduras
RECRUITINGColchester General Hospital
Colchester, United Kingdom
RECRUITINGDiana, Princess of Wales Hospital
Grimsby, United Kingdom
RECRUITINGRoyal Liverpool University Hospital
Liverpool, United Kingdom
RECRUITINGSt Thomas' Hospital
London, United Kingdom
RECRUITINGNumber 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.
Time frame: 1 week
Ease of use evaluation
Ease of Use, as measured by sponsor review of the surgical procedure and surgeon feedback.
Time frame: during the surgery procedure
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.
Time frame: Baseline, 6, 12, and 24 months
Rate of secondary surgical interventions at Month 6, Month 12 and Month 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12 and 24-months
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