A Multi-center, Prospective, Cohort Expansion Clinical Study Evaluating the Safety, Usability, Implantation Accuracy and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma (STAR VII Study)
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).
• 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.