Minimally Invasive Micro Sclerostomy First in Man Safety and Preliminary Performance Study

Sanoculis

Status

Completed

Conditions

Primary Open Angle Glaucoma

Pigmentary Glaucoma

Pseudoexfoliative Glaucoma

Treatments

Procedure: Minimally Invasive Micro Sclerostomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT02355990

SAN-FIM-1

Details and patient eligibility

About

The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
- Use of oral hypotensive medication for glaucoma for treatment of the fellow eye
- Less than the minimum visual function required for driving in the fellow eye: best-corrected visual acuity worse than 20/40 (Snellen equivalent) or Esterman visual field score less than 85%.
- History of idiopathic or autoimmune uveitis in either eye
- Severe trauma in study eye
- active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
- Vitreous present in anterior chamber, prior vitrectomy or virteous hemorrhage in study eye
- Aphakia
- Prior vitreoretinal surgery in study eye
- Clinically significant ocular inflammation or infection within 90 days prior to screening
- Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
- Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits
- Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
- Pregnant or lactating women