NCT05638321

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Sanoculis Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-04-11
• Primary completion: 2024-02-07
• Completion: 2024-03-12
• First posted: 2022-12-06
• Last updated: 2024-03-12

Locations

1 site across 1 country: Armenia