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

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 Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma
• Intervention / Treatment: Procedure: Minimally Invasive Micro Sclerostomy

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel
    • Goldschleger Eye Institute, The Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIMS; Minimally Invasive Micro Sclerostomy	Procedure: Minimally Invasive Micro Sclerostomy; Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall incidence of serious adverse events	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of serious adverse events	24 weeks
intraocular pressure (IOP) between 6 mmHg and 15 mmHg without medication	24 weeks
Change in number of glaucoma medications from baseline in the study eye	24 weeks

Collaborators and Investigators

• Sponsor: Sanoculis Ltd
• Investigators: Principal Investigator: Daniel Cotlear, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: January 31, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: SAN-FIM-1