A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma

Ki vehet részt

• 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:; Capsulorhexis is intact and centered; Posterior capsular bag is intact; The IOL is well-centered in the capsular bag; There is no evidence of zonular dehiscence/rupture; The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy

Ki nem vehet részt

• Any eye surgery that was performed < 90 days before Screening/Baseline visit in the study eye
• Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant
• Anticipated need for ocular surgery or retinal laser procedure in the study eye
• Participation in any study involving a drug or device within the past 3 months and planned participation to any other study during the present study. There is no exclusion period after completion of the present trial
• Unable to discontinue anticoagulant/antiplatelet therapy (i.e. acetylsalicylic acid, coumadin, heparin, apixaban, etc.) for the surgical procedure. The amount of washout and when to restart therapy after surgery is at the Principal Investigator's discretion and may be based on literature references (see Annexes) or in consultation with the subject's primary care team
• Known or suspected allergy or hypersensitivity to medical silicone
• Allergy to fluorescein
• Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders)
• Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye
• Clinically significant intra-ocular inflammation or infection
• Subject has a condition such that his / her ability to provide personal informed consent is compromised
• Diagnosis of diabetes mellitus with HbA1C >7%
• Central endothelial cell density (ECD) at Screening visit with a mean value <1900 cells/mm2 or coefficient of variation (CV) of endothelium >0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism
• Diagnosis of cataract in the study eye that is not age-related e.g., traumatic, inflammatory or resulting from diabetes in the study eye
• Subjects are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:
• Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3
• Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,
• Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation
• Central corneal thickness greater than 600 microns
• Evidence of crystalline lens subluxation or luxation in the study eye
• Inability to perform Visual Field (VF) testing in either eye
• Evidence of vitreous loss in the anterior chamber in the study eye
• Presence of silicone oil in the study eye
• Only for women of childbearing potential: positive pregnancy test at Screening/Baseline visit. Pregnant or lactating women
• Subject is under tutorship or trusteeship