NCT02355990
Completed
Not Applicable
Minimally Invasive Micro Sclerostomy First in Man Safety and Preliminary Performance Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanoculis Ltd
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Overall incidence of serious adverse events
Overview
Brief Summary
The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •End Stage primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye (EGS criteria)
- •Optic nerve appearance characteristic of glaucoma in the study eye
- •Best-corrected visual acuity (BCVA) of counting-fingers, hand movements, light perception or no light perception due to glaucomatous loss of central vision in the study eye
- •Patient is treated with 1 to 5 hypotensive medications in the study eye
- •Unsatisfactory medicated IOP (≥ 18 mmHg) at the screening visit in the study eye
- •Shaffer grade ≥ III in all four angle quadrants in the study eye
- •Subject is able and willing to attend all scheduled follow-up exams
- •Subject understands and signs the informed consent
Exclusion Criteria
- •Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
- •Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- •Closed angle forms of glaucoma in either eye
- •Congenital or developmental glaucoma in either eye
- •Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
- •Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
- •Subject has history of penetrating keratoplasty (PKP)
- •Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.
- •Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
- •Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
Outcomes
Primary Outcomes
Overall incidence of serious adverse events
Time Frame: 12 weeks
Secondary Outcomes
- Incidence of serious adverse events(24 weeks)
- Change in number of glaucoma medications from baseline in the study eye(24 weeks)
- intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication(24 weeks)
Investigators
Study Sites (1)
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