Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanoculis Ltd
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit
Overview
Brief Summary
Minimally Invasive Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP).
MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjunctival space), at the inferonasal quadrant of the eye (i.e., inferonasal sclerostomy).
The drainage channel is created by a sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female ≥ 18 years to ≤ 85 years old
- •Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye
- •Manifest open angle glaucoma (OAG) with typical disc or visual field changes and open iridocorneal angle in the study eye (in accordance with European Glaucoma Society (EGS) criteria 1)
- •Optic nerve appearance characteristic of glaucoma in the study eye
- •Shaffer grade ≥ III in all four angle quadrants in the study eye
- •Subject is treated with 0 to 5 hypotensive medications in the study eye
- •Subject is able and willing to attend all scheduled follow-up exams
- •Subject understands and signs the informed consent
- •In addition, subjects meeting the following criterion will be considered for enrolment into Treatment Arm 2 or Treatment Arm 3 of the trial:
- •Subject with refractory glaucoma, defined as prior failure of filtering procedure and/or uncontrolled IOP on maximally tolerated medical therapy (i.e., ≥ 4 classes of topical IOP-lowering medications, or fewer in the case of tolerability or efficacy issues) . Specifically, subjects who:
Exclusion Criteria
- •Exclusion Criteria
- •Subjects presenting 1 or more of the following criteria will not be enrolled in any of the treatment arms of 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 unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy System procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL)
- •Congenital or developmental glaucoma in either eye
- •Fixation threatening visual-field defects or IOP ≥40 mmHg in the study 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 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
Outcomes
Primary Outcomes
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications at 24-week visit
Time Frame: 24 weeks
• Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or fewer number of medications. Subjects who will undergo reoperation for glaucoma prior to the 24 weeks visit will be considered failures in the analysis.
Secondary Outcomes
No secondary outcomes reported