Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study

NCT ID: NCT05638321

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2024-03-12

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.

Conditions

This Study is Conducted Under Inclusion/ Exclusion Criteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Arm 1

Eyes of subjects with uncontrolled (IOP \> 20 mmHg) open-angle glaucoma (OAG), where IOP is not controlled when using maximum tolerated glaucoma medications

Group Type: EXPERIMENTAL

MIMS

Intervention Type: DEVICE

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.

Treatment Arm 2

Eyes of subjects with uncontrolled (IOP \> 20 mmHg) open-angle glaucoma (OAG), who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications \[Treatment Arm 2 and Treatment Arm 3\].

Group Type: EXPERIMENTAL

MIMS

Intervention Type: DEVICE

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.

Treatment Arm 3

Two (2) inferonasal sclerostomies will be performed by the MIMS® system in the eyes of subjects who failed prior filtering procedure or had uncontrolled IOP on tolerated glaucoma medications (i.e., refractory glaucoma).

Group Type: EXPERIMENTAL

MIMS

Intervention Type: DEVICE

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.

Interventions

MIMS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female ≥ 18 years to ≤ 85 years old

2. Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye

3. 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)

4. Optic nerve appearance characteristic of glaucoma in the study eye

5. Shaffer grade ≥ III in all four angle quadrants in the study eye

6. Subject is treated with 0 to 5 hypotensive medications in the study eye

7. Subject is able and willing to attend all scheduled follow-up exams

8. 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:

9. 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:

• Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery);
• Have neovascular glaucoma;
• Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma

Exclusion Criteria

Subjects presenting 1 or more of the following criteria will not be enrolled in any of the treatment arms of the trial:

1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye

2. 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)

3. Congenital or developmental glaucoma in either eye

4. Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye

5. Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye

6. Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye

7. Subject has history of penetrating keratoplasty (PKP)

8. 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

9. Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye

10. Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye

11. History of idiopathic or autoimmune uveitis in either eye

12. Severe trauma in study eye

13. 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

14. Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye

15. Aphakia

16. Prior vitreoretinal surgery in study eye

17. Clinically significant ocular inflammation or infection within 90 days prior to screening

18. Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions

19. 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

20. Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit

21. Pregnant or lactating women

Additionally, subjects presenting 1 or more of the following criteria will not be enrolled in Treatment Arm 1 of the trial:

22. Prior glaucoma filtering surgery, such as trabeculectomy, in the study eye

23. Prior cilioablative procedure in the study eye

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanoculis Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

S.V.Malayan'S Eye Center

Yerevan, , Armenia

Countries

Armenia

Other Identifiers

MMS EEU-5

Identifier Type: -

Identifier Source: org_study_id