Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study

Eligible Glaucoma patients will undergo pre-surgery examination including:

medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .

The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery.

Patients will be followed up to 52 weeks post operation.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Minimally Invasive Micro Sclerostomy (MIMS)

Detailed Description

Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure.

Description of MIMS procedure:

on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .

creating drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue]. MIMS procedure may be combined with cataract surgery.

Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least one month.

Patients will be followed up to 52 weeks post operation.

The following measurements will be included:

• Intra Ocular Pressure (IOP)
• Best Corrected Visual Acuity (BCVA)
• Slit Lamp Biomicroscopic evaluation
• Anterior Segment Optical coherence tomography (OCT)
• Fundus Examination

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia, 0048
    • S.V.Malayan'S Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female ≥ 18 years
• Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
• Optic nerve appearance characteristic of glaucoma in the study eye
• Patient is treated with 0 to 5 hypotensive medications in the study eye
• Unsatisfactory IOP (≥ 21 mmHg) at the screening visit in the study eye
• If cataract is not present - 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:

• 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 MIMS procedure or the study eye is pseudophakic with PCIOL.
• 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
• Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye
• 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
• 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: Minimally invasive micro sclerostomy (MIMS); create a drainage channel at the sclera-corneal junction	Device: Minimally Invasive Micro Sclerostomy (MIMS); The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure Reduction	Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or less number of medications	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure	Mean change in IOP from baseline	52 weeks
Adverse Event	Incidence of adverse events related to MIMS® device/procedure, throughout the study follow-up	52 weeks

Collaborators and Investigators

• Sponsor: Sanoculis Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

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
• Other Study ID Numbers: CL-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No