Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study

NCT04484155 | Completed

• 1 other identifier: MMS-072-51
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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 24 weeks post operation.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Event

  Overall incidence of serious adverse events

  12 weeks

• Drainage Channel Creation

  Ability to successfully perform a drainage channel

  Index procedure day

Secondary Outcomes (2)

• Serious Adverse Event

  24 Weeks

• Intraocular Pressure

  24 Weeks

Study Arms (1)

Minimally invasive micro sclerostomy (MIMS)

EXPERIMENTAL

create a drainage channel at the sclera-corneal junction

Device: Minimally Invasive Micro Sclerostomy (MIMS)

Interventions

Minimally Invasive Micro Sclerostomy (MIMS) DEVICE

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.

Minimally invasive micro sclerostomy (MIMS)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years
• End stage Primary open-angle glaucoma,pseudoexfoliation glaucoma or pigmentary glaucoma in the study eye
• Optic nerve appearance characteristic of glaucoma in the study eye
• Best-corrected visual acuity (BCVA) with ETDRS charts ≤ 6/60
• 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

You may not qualify if:

• 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 20/50 (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

Sponsors & Collaborators

• Sanoculis Ltd: lead

Study Sites (1)

Dr. Agarwal Eye Hospital Ltd.

Chennai, 600086, India

Location

Related Publications (1)

• Geffen N, Kumar DA, Barayev E, Gershoni A, Rotenberg M, Zahavi A, Glovinsky Y, Agarwal A. Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. J Glaucoma. 2022 Mar 1;31(3):191-200. doi: 10.1097/IJG.0000000000001955.

  PMID: 34731867 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: July 16, 2018
• Primary Completion: March 2, 2020
• Study Completion: March 5, 2020
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)